Standard Diagnostics, Inc
⚠️ Moderate Risk
FEI: 3005097034 • Kyonggi-Do • SOUTH KOREA
FEI Number
3005097034
Location
Kyonggi-Do
Country
SOUTH KOREAAddress
156-68 Hagai-Ri, Giheung-Eup, Yongin-Ei, , Kyonggi-Do, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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).
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2014 | 88LDTREAGENT, GENERAL PURPOSE | Seattle District Office (SEA-DO) | |
| 4/2/2014 | 88LDTREAGENT, GENERAL PURPOSE | Seattle District Office (SEA-DO) | |
| 12/24/2013 | 83NWYTEST, QUALITATIVE, DETECTION OF DENGUE IGM AND IGG ANTIBODIES | Seattle District Office (SEA-DO) | |
| 3/21/2012 | 81MTKKIT, SAMPLE COLLECTION, HIV | New Orleans District Office (NOL-DO) | |
| 11/12/2008 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Seattle District Office (SEA-DO) | |
| 11/12/2008 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Standard Diagnostics, Inc's FDA import refusal history?
Standard Diagnostics, Inc (FEI: 3005097034) has 6 FDA import refusal record(s) in our database, spanning from 11/12/2008 to 4/2/2014.
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. Standard Diagnostics, Inc's FEI number is 3005097034.
What types of violations has Standard Diagnostics, Inc received?
Standard Diagnostics, Inc has been cited for 6 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 Standard Diagnostics, Inc come from?
All FDA import refusal data for Standard Diagnostics, Inc 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.