REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

System, Test, Systemic Lupus Erythematosus

CORGENIX, INC.

The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Igm Anti-prothrombin Semi-quantitative Test Kit.

Pre-market Notification Details

Device IDK001398
510k NumberK001398
Device Name:REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
ClassificationSystem, Test, Systemic Lupus Erythematosus
Applicant CORGENIX, INC. 12061 TEJON ST. Westminster,  CO  80234
ContactNanci Dexter
CorrespondentNanci Dexter
CORGENIX, INC. 12061 TEJON ST. Westminster,  CO  80234
Product CodeDHC  
CFR Regulation Number866.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-03
Decision Date2001-03-30

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