FDA 510(k) Application Details - K151589

Device Classification Name	More FDA Info for this Device
510(K) Number	K151589
Device Name	BD MAX CT/GC/TV, BD MAX INSTRUMENT
Applicant	BECTON, DICKINSON, AND COMPANY 7 LOVETON CIR. MC:694 SPARKS, MD 21152 US Other 510(k) Applications for this Company
Contact	KATIE COYLE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2015
Decision Date	09/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review