FDA 510(k) Application Details - K192719

Device Classification Name	More FDA Info for this Device
510(K) Number	K192719
Device Name	Osom Ultra Plus Flu A&B Test Kit
Applicant	Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Nisha Li Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2019
Decision Date	04/03/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review