FDA 510(k) Application Details - K121797

Device Classification Name	More FDA Info for this Device
510(K) Number	K121797
Device Name	BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
Applicant	Becton, Dickinson and Company 10865 ROAD TO THE CURE, SUITE 200 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	GREGORY P PAYNE, RAC 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	06/19/2012
Decision Date	09/07/2012
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