SEKISUI MEDICAL CO LTD · 89-08 · JAPAN
For SEKISUI MEDICAL CO LTD · 89-08 · JAPAN, 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 JAPAN; 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 2026-09-16.
- 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 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/30/2021 Desc: Acucy SARS-CoV-2 Antigen Test with the Acucy System
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.