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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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