REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826

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 Von Willebrand Factor Activity Test Kit, Model 10826.

Pre-market Notification Details

Device IDK032139
510k NumberK032139
Device Name:REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
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 Received2003-07-11
Decision Date2004-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855360006267 K032139 000

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