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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
510(k) Number K163536
Device Name MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
Applicant
Bruker Daltonik GmbH
Fahrenheitstrasse 4
Bremen,  DE 28359
Applicant Contact MARKUS KOSTRZEWA
Correspondent
Bruker Daltonics, Inc.
40 Manning Rd.
Billerica,  MA  01821
Correspondent Contact DAVID CROMWICK
Regulation Number866.3361
Classification Product Code
PEX  
Date Received12/16/2016
Decision Date 07/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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