Acon Biotech (Hangzhou) Co., Ltd.
⚠️ High Risk
FEI: 3002829675 • Hangzhou, Zhejiang • CHINA
FEI Number
3002829675
Location
Hangzhou, Zhejiang
Country
CHINAAddress
No. 210 Zhenzhong Road, West Lake District, Hangzhou, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2024 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 5/15/2024 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 8/22/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/2/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/25/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 5/17/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 237NO PMA | Division of Southwest Imports (DSWI) |
| 4/28/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/8/2022 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/8/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 4/7/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/6/2022 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/1/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 3/30/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/25/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 3/10/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/24/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/23/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 2/22/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/22/2022 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 2/18/2022 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/18/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/16/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/15/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/15/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/15/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/15/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/14/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 2/11/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/11/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/9/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/9/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/8/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/8/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/8/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 2/4/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 2/1/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/1/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 1/27/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/13/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/8/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/17/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/16/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/16/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 2/4/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/4/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/16/2010 | 91DIOENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 8/16/2010 | 91DJGENZYME IMMUNOASSAY, OPIATES | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 8/16/2010 | 91DKZENZYME IMMUNOASSAY, AMPHETAMINE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 8/16/2010 | 91DKZENZYME IMMUNOASSAY, AMPHETAMINE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 8/16/2010 | 91DKZENZYME IMMUNOASSAY, AMPHETAMINE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 4/27/2010 | 91DKZENZYME IMMUNOASSAY, AMPHETAMINE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 6/26/2009 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | Seattle District Office (SEA-DO) | |
| 6/26/2009 | 91DIOENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES | 341REGISTERED | Seattle District Office (SEA-DO) |
| 6/26/2009 | 82KTNSYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 341REGISTERED | Seattle District Office (SEA-DO) |
| 6/26/2009 | 83LYRCAMPYLOBACTER PYLORI | 341REGISTERED | Seattle District Office (SEA-DO) |
| 6/26/2009 | 82NOETEST, SYSTEM, IMMUNOASSAY, LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 | 341REGISTERED | Seattle District Office (SEA-DO) |
| 6/26/2009 | 91LDJENZYME IMMUNOASSAY, CANNABINOIDS | 341REGISTERED | Seattle District Office (SEA-DO) |
| 6/26/2009 | 81MTNTEST, SYPHILIS, TREPONEMAL | Seattle District Office (SEA-DO) | |
| 6/26/2009 | 83OAXPLASMODIUM SPP. DETECTION REAGENTS | Seattle District Office (SEA-DO) | |
| 6/26/2009 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | Seattle District Office (SEA-DO) | |
| 6/26/2009 | 83LJCENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP) | Seattle District Office (SEA-DO) | |
| 6/26/2009 | 73OFZBLOOD SPECIMEN COLLECTION KIT (EXCLUDES HIV TESTING) | Seattle District Office (SEA-DO) | |
| 6/26/2009 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 11/10/2008 | 82MZFTEST, HIV DETECTION | San Francisco District Office (SAN-DO) | |
| 11/21/2007 | 91DIOENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES | 341REGISTERED | Detroit District Office (DET-DO) |
| 11/7/2007 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | Detroit District Office (DET-DO) |
| 10/23/2007 | 83GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 341REGISTERED | Detroit District Office (DET-DO) |
| 10/23/2007 | 82KTNSYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/23/2007 | 83JXAKIT, SCREENING, URINE | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/23/2007 | 81KHEREAGENT, OCCULT BLOOD | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/23/2007 | 81KHEREAGENT, OCCULT BLOOD | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/23/2007 | 83GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/23/2007 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Detroit District Office (DET-DO) | |
| 8/23/2007 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Detroit District Office (DET-DO) | |
| 5/16/2007 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/16/2007 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/23/2006 | 75MGXTEST SYSTEM, FOR DRUGS OF ABUSE | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/8/2006 | 81LJXTEST, URINE LEUKOCYTE | New York District Office (NYK-DO) | |
| 5/8/2006 | 81LJXTEST, URINE LEUKOCYTE | New York District Office (NYK-DO) | |
| 5/8/2006 | 81LJXTEST, URINE LEUKOCYTE | New York District Office (NYK-DO) | |
| 5/8/2006 | 75JILENZYMATIC METHOD, GLUCOSE (URINARY, NON-QUANT.) | New York District Office (NYK-DO) | |
| 5/8/2006 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 5/8/2006 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 12/5/2005 | 91MIGSTRIP, TEST ISONIAZID | Southwest Import District Office (SWI-DO) | |
| 6/9/2005 | 85MEEDEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE | 237NO PMA | Chicago District Office (CHI-DO) |
| 6/2/2005 | 85MEEDEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE | New York District Office (NYK-DO) | |
| 6/2/2005 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 4/25/2005 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 508NO 510(K) | Chicago District Office (CHI-DO) |
| 4/25/2005 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 508NO 510(K) | Chicago District Office (CHI-DO) |
| 1/9/2003 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Acon Biotech (Hangzhou) Co., Ltd.'s FDA import refusal history?
Acon Biotech (Hangzhou) Co., Ltd. (FEI: 3002829675) has 101 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 6/18/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Acon Biotech (Hangzhou) Co., Ltd.'s FEI number is 3002829675.
What types of violations has Acon Biotech (Hangzhou) Co., Ltd. received?
Acon Biotech (Hangzhou) Co., Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Acon Biotech (Hangzhou) Co., Ltd. come from?
All FDA import refusal data for Acon Biotech (Hangzhou) Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.