Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 4 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sekisui Chemical and its 4 subsidiaries with 23 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Apr 18, 2025: Acucy® Influenza A&B Test with the Acucy® 2 System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sekisui Chemical and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 18, 2025 | Acucy® Influenza A&B Test with the Acucy® 2 SystemK241188 · PSZ | 510(k) clearances |
| Feb 18, 2022 | AcetaminophenK202644 · LDP | 510(k) clearances |
| Apr 3, 2020 | Osom Ultra Plus Flu A&B Test KitK192719 · PSZ | 510(k) clearances |
| Apr 17, 2019 | SEKURE Creatine Kinase AssayK182702 · CGS | 510(k) clearances |
| Feb 8, 2019 | SEKURE Acetaminophen L3K AssayK180835 · LDP | 510(k) clearances |
| Dec 17, 2018 | Acucy Influenza A&B Test with the Acucy SystemK182001 · PSZ | 510(k) clearances |
| Jul 12, 2018 | SEKURE HbA1c AssayK173206 · PDJ | 510(k) clearances |
| Jun 22, 2018 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestK181436 · KTN | 510(k) clearances |
| Sep 16, 2013 | Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitativClass II · Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
