RHIGENE HEP-ANA TEST SYSTEM

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

CORGENIX, INC.

The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Rhigene Hep-ana Test System.

Pre-market Notification Details

Device IDK042680
510k NumberK042680
Device Name:RHIGENE HEP-ANA TEST SYSTEM
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant CORGENIX, INC. 455 STATE STREET Des Plaines,  IL  60016
ContactYusuke Kobe
CorrespondentYusuke Kobe
CORGENIX, INC. 455 STATE STREET Des Plaines,  IL  60016
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-29
Decision Date2004-11-19
Summary:summary

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