Sugentech, Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Sugentech, 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 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 2026-09-30.
- 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)
— 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: SGTi-flex 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