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FDA 510(k) Application Details - K161810
Device Classification Name
System, Blood Culturing
More FDA Info for this Device
510(K) Number
K161810
Device Name
System, Blood Culturing
Applicant
BECTON DICKINSON
7 LOVETON CIRCLE, MC 694
Sparks, MD 21152 US
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Contact
Ashanti C. Brown
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
07/01/2016
Decision Date
02/09/2017
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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