GC Cell Corp · 89-08 · KOREA (THE REPUBLIC OF)
For GC Cell Corp, import alert is 89-08; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is GENEDIA W COVID-19 Ag; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is 107 Ihyeonro30beon-Gil; Giheung , Yongin, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- GC Cell Corp verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 107 Ihyeonro30beon-Gil; Giheung , Yongin, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- GENEDIA W COVID-19 Ag verified
What the source says
GC Cell Corp Date Published : 07/27/2021 107 Ihyeonro30beon-Gil; Giheung , Yongin, Gyeonggi KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: GENEDIA W COVID-19 Ag
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html