FDA 510(k) Application Details - DEN170081

Device Classification Name

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510(K) Number DEN170081
Device Name MALDI Biotyper CA System
Applicant Bruker Daltonik GmbH
Fahrenheitstrasse 4
Bremen 28359 DE
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Contact Markus Kostrzewa
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Regulation Number

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Classification Product Code QBN
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Date Received 09/29/2017
Decision Date 04/20/2018
Decision DENG -
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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