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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, Anticardiolipin Immunological
510(k) Number K032868
Device Name REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
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
MID  
Subsequent Product Codes
DHC   MSV  
Date Received09/15/2003
Decision Date 10/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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