REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001

System, Test, Anticardiolipin Immunological

CORGENIX, INC.

The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Anti-cardiolipin Igg/igm Semi-quantitative Test Kit, Model 023-001.

Pre-market Notification Details

Device IDK022992
510k NumberK022992
Device Name:REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
ClassificationSystem, Test, Anticardiolipin Immunological
Applicant CORGENIX, INC. 12061 TEJON ST. Westminster,  CO  80234
ContactNanci Dexter
CorrespondentNanci Dexter
CORGENIX, INC. 12061 TEJON ST. Westminster,  CO  80234
Product CodeMID  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-09
Decision Date2002-09-25

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