SEKISUI Diagnostics, LLC - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by SEKISUI Diagnostics, LLC Microbiology ✕
5 devices
Cleared
Apr 18, 2025
Acucy® Influenza A&B Test with the Acucy® 2 System
Microbiology
354d
Cleared
Apr 03, 2020
Osom Ultra Plus Flu A&B Test Kit
Microbiology
190d
Cleared
Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
Microbiology
144d
Cleared
Jun 22, 2018
OSOM Mono Test
Microbiology
21d
Cleared
Nov 05, 2012
OSOM INFLUENZA A&B TEST MODEL 190
Microbiology
26d