FDA 510(k) Application Details - K160161

Device Classification Name	More FDA Info for this Device
510(K) Number	K160161
Device Name	BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Applicant	Becton, Dickinson & Co. 10865 Road to the Cure, Suite 200 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Gregory P. 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	01/27/2016
Decision Date	02/24/2016
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