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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name mass spectrometry, maldi tof, microorganism identification, cultured isolates
De Novo Number DEN170081
Device Name MALDI Biotyper CA System
Requester
Bruker Daltonik GmbH
fahrenheitstrasse 4
bremen,  DE 28359
Contact markus kostrzewa
Regulation Number866.3378
Classification Product Code
QBN  
Date Received09/29/2017
Decision Date 04/20/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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