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FDA 510(k) Application Details - K113558
Device Classification Name
System, Blood Culturing
More FDA Info for this Device
510(K) Number
K113558
Device Name
System, Blood Culturing
Applicant
Becton, Dickinson and Company
7 LOVETON CIRCLE
MC 614
SPARKS, MD 21043 US
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Contact
Paul Swift
Other 510(k) Applications for this Contact
Regulation Number
866.2560
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Classification Product Code
MDB
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More FDA Info for this Product Code
Date Received
12/01/2011
Decision Date
03/16/2012
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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