FDA 510(k) Application Details - K182692

Device Classification Name	More FDA Info for this Device
510(K) Number	K182692
Device Name	BD MAX CTGCTV2, BD MAX System
Applicant	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Katie Edwards 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	09/27/2018
Decision Date	01/08/2019
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