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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Contact 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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