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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 K982433
Device Name REAADS IGM ANTI-B2GP1 TEST KIT
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  
Date Received07/14/1998
Decision Date 12/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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