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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 K012567
Device Name MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM 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 Number866.5660
Classification Product Code
MID  
Date Received08/09/2001
Decision Date 08/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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