Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

SEKISUI Diagnostics, LLC

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K241188	Acucy® Influenza A&B Test with the Acucy® 2 System	PSZ	2025-04-18	View
510(k)	K192719	Osom Ultra Plus Flu A&B Test Kit	PSZ	2020-04-03	View
510(k)	K182001	Acucy Influenza A&B Test with the Acucy System	PSZ	2018-12-17	View
510(k)	K181436	OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test	KTN	2018-06-22	View
510(k)	K121397	OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT	KHE	2012-12-28	View
510(k)	K123182	OSOM INFLUENZA A&B TEST MODEL 190	GNX	2012-11-05	View

↑