EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)

Antibodies, Gliadin

EUROIMMUN US INC

The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-gliadin (gaf-3x) Elisa (iga).

Pre-market Notification Details

Device IDK083052
510k NumberK083052
Device Name:EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
ClassificationAntibodies, Gliadin
Applicant EUROIMMUN US INC 95 WASHINGTON ST Morristown,  NJ  07960
ContactKathryn Kohl
CorrespondentKathryn Kohl
EUROIMMUN US INC 95 WASHINGTON ST Morristown,  NJ  07960
Product CodeMST  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-14
Decision Date2009-07-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049016035930 K083052 000

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