REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

System, Test, Anticardiolipin Immunological

CORGENIX, INC.

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

Pre-market Notification Details

Device IDK000920
510k NumberK000920
Device Name:REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-22
Decision Date2000-04-26

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