NDFOS CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
For NDFOS CO LTD · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; 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)"; country is KOREA (THE REPUBLIC OF); product is ND COVID-19 IgG/IgM Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is 1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- NDFOS CO LTD 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
- 1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido KOREA (THE REPUBLIC OF) verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- ND COVID-19 IgG/IgM Rapid Test verified
What the source says
NDFOS CO LTD Date Published : 03/11/2021 1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: ND COVID-19 IgG/IgM Rapid Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.