SEKISUI MEDICAL CO LTD · 89-08 · JAPAN
For SEKISUI MEDICAL CO LTD, import alert is 89-08; country is JAPAN; 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 Acucy SARS-CoV-2 Antigen Test with the Acucy System; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 09/30/2021; address is 3262-12 , Oazaami; Ami-Machi , Inashiki-Gun, Ibaraki JAPAN, verified against its source on 2026-09-30.
- Firm
- SEKISUI MEDICAL CO LTD 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
- JAPAN verified
- Address
- 3262-12 , Oazaami; Ami-Machi , Inashiki-Gun, Ibaraki JAPAN verified
- Date published
- 09/30/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- Acucy SARS-CoV-2 Antigen Test with the Acucy System verified
What the source says
SEKISUI MEDICAL CO LTD Date Published : 09/30/2021 3262-12 , Oazaami; Ami-Machi , Inashiki-Gun, Ibaraki JAPAN
— 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: 09/30/2021 Desc: Acucy SARS-CoV-2 Antigen Test with the Acucy System
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html