FDA 510(k) Applications for Medical Device Product Code "PEX"

FDA 510(k) Number Applicant Device Name Decision Date
DEN130013 BIOMERIEUX, INC. VITEK MS 08/21/2013
K162950 bioMerieux, Inc. VITEK MS 07/22/2017
K130831 BRUKER DALTONICS, INC MALDI BIOTYPER CA (MBT-CA) SYSTEM 11/21/2013
K142677 BRUKER DALTONICS, INC MALDI Biotyper CA System 03/27/2015
K163536 BRUKER DALTONIK GMBH MALDI Biotyper CA (MBT-CA) System, MBT smart CA System 07/26/2017


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