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FDA 510(k) Application Details - K032139
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K032139
Device Name
Test, Qualitative And Quantitative Factor Deficiency
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
864.7290
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Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
07/11/2003
Decision Date
04/05/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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