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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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