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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 K142677
Device Name MALDI Biotyper CA System
Applicant
Bruker Daltonics, Inc.
40 Manning Rd.
Billerica,  MA  01821
Applicant Contact Ken Hirakawa
Correspondent
Bruker Daltonics, Inc.
Fahrenheilstrasse-4
Bremen,  DE 28359
Correspondent Contact Markus Kostrzewa
Regulation Number866.3361
Classification Product Code
PEX  
Date Received09/19/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02098226
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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