FDA 510(k) Application Details - K981973

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

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510(K) Number K981973
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant RAM SCIENTIFIC
1201 NEW YORK AVENUE N.W.
SUITE 1000
WASHINGTON, DC 20005 US
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Contact GEOFFREY LEVITT
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Regulation Number 862.1675

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Classification Product Code JKA
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Date Received 06/05/1998
Decision Date 09/03/1998
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



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