Sugentech, Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Sugentech, 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 SGTi-flex COVID-19 Ag; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is 721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu , 187, techno 2-ro, yuseong-gu , Cheongju, Chungcheongbug KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Sugentech, 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
- 721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu , 187, techno 2-ro, yuseong-gu , Cheongju, Chungcheongbug KOREA (THE REPUBLIC OF) verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- SGTi-flex COVID-19 Ag verified
What the source says
Sugentech, Inc. Date Published : 07/27/2021 721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu , 187, techno 2-ro, yuseong-gu , Cheongju, Chungcheongbug KOREA (THE REPUBLIC OF) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: SGTi-flex COVID-19 Ag
— 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.