FDA 510(k) Application Details - K063852

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

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510(K) Number K063852
Device Name Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant HOME ACCESS HEALTH CORP.
2401 W. HASSELL
SUITE 1510
HOFFMAN ESTATES, IL 60195-5200 US
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Contact KAREN L HANSON
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Regulation Number 862.1675

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Classification Product Code JKA
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Date Received 12/28/2006
Decision Date 11/09/2007
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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