CALTH INC · 89-08 · KOREA (THE REPUBLIC OF) (7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF))
For CALTH INC (7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF)), 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 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 2026-09-30.
- Firm
- CALTH 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
- 7508, 140, Beolmal-Ro , Gyeinggi-Do, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/28/2020 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- AccuFind COVID19 IgG verified
What the source says
CALTH INC Date Published : 12/28/2020 7508, 140, Beolmal-Ro , Gyeinggi-Do, 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 - - KO Reagent, coronavirus serological Date Published: 12/28/2020 Desc: AccuFind COVID19 IgG
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html