FDA 510(k) Application Details - K974873

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

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510(K) Number K974873
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant GREINER MEDITECH, INC.
260 GATEWAY DRIVE, SUITE 17A
BEL AIR, MD 21014 US
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Contact DOUGLAS L HARRIS
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Regulation Number 862.1675

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Classification Product Code JKA
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Date Received 12/29/1997
Decision Date 02/05/1998
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

FDA Source Information for K974873


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