PLEXENSE, INC · 89-08 · KOREA (THE REPUBLIC OF)
For PLEXENSE, 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 ACCEL ELISA COVID-19; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Giheung , 1301 1302, 1303 16-4 Dongbaekjungang-Ro , Yongin, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- PLEXENSE, 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
- Giheung , 1301 1302, 1303 16-4 Dongbaekjungang-Ro , Yongin, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- ACCEL ELISA COVID-19 verified
What the source says
PLEXENSE, INC Date Published : 01/26/2021 Giheung , 1301 1302, 1303 16-4 Dongbaekjungang-Ro , Yongin, Gyeonggi 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: 01/26/2021 Desc: ACCEL ELISA COVID-19
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html