FDA 510(k) Application Details - K101461

Device Classification Name	More FDA Info for this Device
510(K) Number	K101461
Device Name	BD DIRECTIGEN EX FLU A+B
Applicant	Becton, Dickinson and Company 11085 NORTH TORREY PINES ROAD SUITE 210 LA JOLLA, CA 92037 US Other 510(k) Applications for this Company
Contact	GREGORY 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	05/26/2010
Decision Date	06/24/2010
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