FDA 510(k) Application Details - K232434

Device Classification Name	More FDA Info for this Device
510(K) Number	K232434
Device Name	BD VeritorÖ 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	Michelle Bowerman 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	08/11/2023
Decision Date	12/05/2023
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