FDA 510(k) Application Details - K974883

Device Classification Name System, Blood Culturing

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510(K) Number K974883
Device Name System, Blood Culturing
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE, MD 21030-0243 US
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Contact JODY J HOFFMANN
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Regulation Number 866.2560

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Classification Product Code MDB
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Date Received 12/30/1997
Decision Date 05/01/1998
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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