FDA 510(k) Application Details - K022992

Device Classification Name System, Test, Anticardiolipin Immunological

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510(K) Number K022992
Device Name System, Test, Anticardiolipin Immunological
Applicant CORGENIX, INC.
12061 TEJON ST.
WESTMINSTER, CO 80234 US
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Contact NANCI DEXTER
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Regulation Number 866.5660

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Classification Product Code MID
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Date Received 09/09/2002
Decision Date 09/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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