FDA 510(k) Application Details - K063689

Device Classification Name	More FDA Info for this Device
510(K) Number	K063689
Device Name	BD DIRECTIGEN EZ FLU A+B TEST
Applicant	BECTON DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US Other 510(k) Applications for this Company
Contact	DAINELLE N CLARK 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	12/12/2006
Decision Date	03/07/2007
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