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FDA 510(k) Application Details - K024196
Device Classification Name
System, Test, Anticardiolipin Immunological
More FDA Info for this Device
510(K) Number
K024196
Device Name
System, Test, Anticardiolipin Immunological
Applicant
CORGENIX, INC.
12061 TEJON ST.
WESTMINSTER, CO 80234 US
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Contact
NANCI DEXTER
Other 510(k) Applications for this Contact
Regulation Number
866.5660
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Classification Product Code
MID
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More FDA Info for this Product Code
Date Received
12/20/2002
Decision Date
01/03/2003
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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