FDA 510(k) Application Details - K152874

Device Classification Name	More FDA Info for this Device
510(K) Number	K152874
Device Name	BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
Applicant	BECTON DICKINSON, AND CO. 10865 ROAD TO THE CURE, SUITE 200 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	GREG PAYNE 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	09/30/2015
Decision Date	10/27/2015
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