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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
510(k) Number K031208
Device Name REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
Applicant
Corgenix, Inc.
12061 Tejon St.
Westminster,  CO  80234
Applicant Contact NANCI DEXTER
Correspondent
Corgenix, Inc.
12061 Tejon St.
Westminster,  CO  80234
Correspondent Contact NANCI DEXTER
Regulation Number866.5660
Classification Product Code
MSV  
Subsequent Product Code
DHC  
Date Received04/17/2003
Decision Date 07/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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