FDA 510(k) Application Details - K093972

Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection

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510(K) Number K093972
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant BECTON DICKINSON & CO.
1 BECTON DRIVE, MC 300
FRANKLIN LAKES, NJ 07417-1880 US
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Contact JULIE T WING
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Regulation Number 862.1675

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Classification Product Code JKA
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Date Received 12/24/2009
Decision Date 01/21/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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