ABBOTT DIAGNOSTICS KOREA INC
⚠️ Moderate Risk
FEI: 3015883679 • Yongin, Gyeonggi • SOUTH KOREA
FEI Number
3015883679
Location
Yongin, Gyeonggi
Country
SOUTH KOREAAddress
65 Borahagal-Ro, Giheung, 65 Borahagal-Lo; Giheung, Yongin, Gyeonggi, 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
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.
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).
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.
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).
3905
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2025 | 83OAXPLASMODIUM SPP. DETECTION REAGENTS | Division of Southeast Imports (DSEI) | |
| 2/14/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 1/31/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/7/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ABBOTT DIAGNOSTICS KOREA INC's FDA import refusal history?
ABBOTT DIAGNOSTICS KOREA INC (FEI: 3015883679) has 4 FDA import refusal record(s) in our database, spanning from 7/7/2021 to 12/2/2025.
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. ABBOTT DIAGNOSTICS KOREA INC's FEI number is 3015883679.
What types of violations has ABBOTT DIAGNOSTICS KOREA INC received?
ABBOTT DIAGNOSTICS KOREA INC has been cited for 5 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 ABBOTT DIAGNOSTICS KOREA INC come from?
All FDA import refusal data for ABBOTT DIAGNOSTICS KOREA 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.