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FDA 510(k) Application Details - K091292
Device Classification Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
More FDA Info for this Device
510(K) Number
K091292
Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant
BECTON DICKINSON AND COMPANY (BD)
1 BECTON DRIVE. MC300
FRANKLIN LAKES, NJ 07417-1885 US
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Contact
MARY ANN ALSBERGE
Other 510(k) Applications for this Contact
Regulation Number
862.1675
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Classification Product Code
JKA
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More FDA Info for this Product Code
Date Received
05/04/2009
Decision Date
08/25/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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