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FDA 510(k) Application Details - K031208
Device Classification Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
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510(K) Number
K031208
Device Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Applicant
CORGENIX, INC.
12061 TEJON ST.
WESTMINSTER, CO 80234 US
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NANCI DEXTER
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Regulation Number
866.5660
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Classification Product Code
MSV
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Date Received
04/17/2003
Decision Date
07/07/2003
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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