FDA 510(k) Application Details - K160911

Device Classification Name	More FDA Info for this Device
510(K) Number	K160911
Device Name	VIDAS B.R.A.H.M.S. PCT (PCT)
Applicant	bioMerieux, Inc 595 Anglum Rd. Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Thi My Lan Dang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2016
Decision Date	06/28/2016
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