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FDA 510(k) Application Details - K193419
Device Classification Name
More FDA Info for this Device
510(K) Number
K193419
Device Name
MBT Sepsityper
Applicant
Bruker Daltonik GmbH
Fahrenheitstrasse 4
Bremen 28359 DE
Other 510(k) Applications for this Company
Contact
Peter Trinder
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QNJ
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More FDA Info for this Product Code
Date Received
12/09/2019
Decision Date
12/27/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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