# Sugentech, Inc. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu , 187, techno 2-ro, yuseong-gu , Cheongju, Chungcheongbug KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 07/27/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** SGTi-flex COVID-19 Ag _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).