PCL INC · 89-08 · KOREA (THE REPUBLIC OF)
For PCL 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 PCL COVID19 Ag Rapid FIA; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is Rm 701 Star Valley 99 Digital-Ro 9-Gil , Geumcheon, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- PCL 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
- Rm 701 Star Valley 99 Digital-Ro 9-Gil , Geumcheon, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- PCL COVID19 Ag Rapid FIA verified
What the source says
PCL INC Date Published : 06/22/2021 Rm 701 Star Valley 99 Digital-Ro 9-Gil , Geumcheon, Seoul Teugbyeolsi 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: 06/22/2021 Desc: PCL COVID19 Ag Rapid FIA
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html