MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE 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 Modification To Reaads Anti-phosphatidylserine Iga Semi-quantative Test Kit.

Pre-market Notification Details

Device IDK024195
510k NumberK024195
Device Name:MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-20
Decision Date2003-01-03

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