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FDA 510(k) Application Details - K023971
Device Classification Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
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510(K) Number
K023971
Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant
GREINER BIO-ONE VACUETTE NORTH AMERICA
PO BOX 103
BALDWIN, MD 21013 US
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Contact
Judi Smith
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
11/29/2002
Decision Date
01/27/2003
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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