SEKISUI Diagnostics, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
SEKISUI Diagnostics, LLC - FDA 510(k) Cleared Devices
Recent clearances: Acucy® Influenza A&B Test with the Acucy® 2 System, Osom Ultra Plus Flu A&B Test Kit, Acucy Influenza A&B Test with the Acucy System
6
Total
6
Cleared
0
Denied
SEKISUI Diagnostics, LLC has 6 FDA 510(k) cleared medical devices. Based in San Diegi, US.
Latest FDA clearance: Apr 2025. Active since 2012. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by SEKISUI Diagnostics, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - SEKISUI Diagnostics, LLC
6 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
Dec 28, 2012
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB...
Hematology
233d
Cleared
Nov 05, 2012
OSOM INFLUENZA A&B TEST MODEL 190
Microbiology
26d