BBB INC · 89-08 · KOREA (THE REPUBLIC OF)
For BBB INC, 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 MARK-B%u2122 COVID-19 Ag; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is 7F, Teheran-ro 81-gil , Gangnam-gu , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- BBB 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
- 7F, Teheran-ro 81-gil , Gangnam-gu , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- MARK-B%u2122 COVID-19 Ag verified
What the source says
BBB INC Date Published : 07/27/2021 7F, Teheran-ro 81-gil , Gangnam-gu , Seoul, 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: MARK-B%u2122 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
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.