FDA 510(k) Application Details - K223016

Device Classification Name	More FDA Info for this Device
510(K) Number	K223016
Device Name	BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
Applicant	BD 7 Loveton Cir Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Dung Nguyen 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	09/29/2022
Decision Date	01/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review