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FDA 510(k) Application Details - K130831
Device Classification Name
More FDA Info for this Device
510(K) Number
K130831
Device Name
MALDI BIOTYPER CA (MBT-CA) SYSTEM
Applicant
BRUKER DALTONICS, INC
180 Cabot Street
Beverly, MA 01915 US
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Contact
FRAN WHITE
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Regulation Number
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Classification Product Code
PEX
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More FDA Info for this Product Code
Date Received
03/26/2013
Decision Date
11/21/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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