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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometry, Microorganism Identification, Blood Culture
510(k) Number K193419
Device Name MBT Sepsityper
Applicant
Bruker Daltonik GmbH
Fahrenheitstrasse 4
Bremen,  DE 28359
Applicant Contact Peter Trinder
Correspondent
Bruker Daltonik GmbH
Fahrenheitstrasse 4
Bremen,  DE 28359
Correspondent Contact Peter Trinder
Classification Product Code
QNJ  
Date Received12/09/2019
Decision Date 12/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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