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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, Systemic Lupus Erythematosus
510(k) Number K001398
Device Name REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE 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 Number866.5820
Classification Product Code
DHC  
Date Received05/03/2000
Decision Date 03/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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