SEKISUI Diagnostics, LLC
6 FDA 510(k) clearances · Manufacturer
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Acucy® Influenza A&B Test with the Acucy® 2 System (K241188) | SEKISUI Diagnostics, LLC | 2025-04-18 |
| Osom Ultra Plus Flu A&B Test Kit (K192719) | SEKISUI Diagnostics, LLC | 2020-04-03 |
| Acucy Influenza A&B Test with the Acucy System (K182001) | SEKISUI Diagnostics, LLC | 2018-12-17 |
| OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (K181436) | SEKISUI Diagnostics, LLC | 2018-06-22 |
| OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT (K121397) | SEKISUI Diagnostics, LLC | 2012-12-28 |
| OSOM INFLUENZA A&B TEST MODEL 190 (K123182) | SEKISUI Diagnostics, LLC | 2012-11-05 |
Track SEKISUI Diagnostics, LLC automatically
Every clearance here is in the API, with alerts when new ones post.