FDA 510(k) Application Details - K163536

Device Classification Name	More FDA Info for this Device
510(K) Number	K163536
Device Name	MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
Applicant	BRUKER DALTONIK GMBH FAHRENHEITSTRASSE 4 BREMEN 28359 DE Other 510(k) Applications for this Company
Contact	MARKUS KOSTRZEWA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2016
Decision Date	07/26/2017
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