FDA 510(k) Application Details - K083572

Device Classification Name System, Blood Culturing

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510(K) Number K083572
Device Name System, Blood Culturing
Applicant BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152 US
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Contact DENNIS MERTZ
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Regulation Number 866.2560

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Classification Product Code MDB
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Date Received 12/03/2008
Decision Date 12/24/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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