FDA 510(k) Application Details - K001364

Device Classification Name	More FDA Info for this Device
510(K) Number	K001364
Device Name	BD DIRECTIGEN FLU A+B
Applicant	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE SPARKS, MD 21152-0999 US Other 510(k) Applications for this Company
Contact	Monica Giguere 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	05/01/2000
Decision Date	06/28/2000
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