REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT

Test, Qualitative And Quantitative Factor Deficiency

CORGENIX, INC.

The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Monoclonal Free Protein S Antigen Test Kit.

Pre-market Notification Details

Device IDK983914
510k NumberK983914
Device Name:REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant CORGENIX, INC. 12061 TEJON ST. Westminster,  CO  80234
ContactNanci Dexter
CorrespondentNanci Dexter
CORGENIX, INC. 12061 TEJON ST. Westminster,  CO  80234
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-04
Decision Date1998-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855360006014 K983914 000

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