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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 K130831
Device Name MALDI BIOTYPER CA (MBT-CA) SYSTEM
Applicant
BRUKER DALTONICS, INC
180 Cabot Street
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
BRUKER DALTONICS, INC
180 Cabot Street
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number866.3361
Classification Product Code
PEX  
Date Received03/26/2013
Decision Date 11/21/2013
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
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