FDA 510(k) Application Details - K003062

Device Classification Name	Susceptibility Test Powders, Antimycobacterial   More FDA Info for this Device
510(K) Number	K003062
Device Name	Susceptibility Test Powders, Antimycobacterial
Applicant	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE SPARKS, MD 21152-0999 US Other 510(k) Applications for this Company
Contact	DENNIS R MERTZ Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	MJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2000
Decision Date	06/06/2001
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