FDA 510(k) Application Details - K151866

Device Classification Name System, Blood Culturing

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510(K) Number K151866
Device Name System, Blood Culturing
Applicant BECTON DICKINSON AND COMPANY
7 LOVETON CIRCLE, MC 694
SPARKS, MD 21152 US
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Contact ASHANTI C. BROWN
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Regulation Number 866.2560

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Classification Product Code MDB
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Date Received 07/09/2015
Decision Date 02/25/2016
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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