FDA 510(k) Application Details - K132693

Device Classification Name	More FDA Info for this Device
510(K) Number	K132693
Device Name	BD VeritorÖ System Flu A+B Assay
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	08/29/2013
Decision Date	10/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review