# ASAN PHARM CO LTD · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For ASAN PHARM CO LTD · 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 Asan Easy Test Covid-19 IgG/IgM | Asan Easy Test Covid-19 IgG/IgM | Asan Easy Test Covid-19 IgG/IgM; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 09/17/2020; address is 485 Cheonggyecheon-Ro D , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** ASAN PHARM CO LTD _(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:** 485 Cheonggyecheon-Ro D , Seoul, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 09/17/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** Asan Easy Test Covid-19 IgG/IgM | Asan Easy Test Covid-19 IgG/IgM | Asan Easy Test Covid-19 IgG/IgM _(verified: each item appears in the quote below)_

## What the source says

> ASAN PHARM CO LTD Date Published : 09/17/2020 485 Cheonggyecheon-Ro D , Seoul, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/17/2020 Desc: Asan Easy Test Covid-19 IgG/IgM 83 Q - - KO Reagent, coronavirus serological Date Published: 09/17/2020 Desc: Asan Easy Test Covid-19 IgG/IgM 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/17/2020 Desc: Asan Easy Test Covid-19 IgG/IgM

## 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/).