CALTH INC. · 89-08 · KOREA (THE REPUBLIC OF)
For CALTH INC. · 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 AccuFind COVID19 IgG; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 12/28/2020; address is #321, 54, Changeop-Ro,S , Gyeonggi-Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- CALTH INC. 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
- #321, 54, Changeop-Ro,S , Gyeonggi-Do, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/28/2020 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- AccuFind COVID19 IgG verified
What the source says
CALTH INC. Date Published : 12/28/2020 #321, 54, Changeop-Ro,S , Gyeonggi-Do, KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 12/28/2020 Desc: AccuFind COVID19 IgG
— 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.