# SEKISUI MEDICAL CO LTD · 89-08 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 3262-12 , Oazaami; Ami-Machi , Inashiki-Gun, Ibaraki JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** Acucy SARS-CoV-2 Antigen Test with the Acucy System _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).