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

For CALTH 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 AccuFind COVID19 IgG; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 12/28/2020; address is 7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** CALTH 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:** 7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 12/28/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** AccuFind COVID19 IgG _(verified: appears in the quote below)_

## What the source says

> CALTH INC Date Published : 12/28/2020 7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 12/28/2020 Desc: AccuFind COVID19 IgG

## 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/).