EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)

Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis

EUROIMMUN US

The following data is part of a premarket notification filed by Euroimmun Us with the FDA for Euroimmun Euroline Profile Autoimmune Liver Disease 8ag (igg).

Pre-market Notification Details

Device IDK113439
510k NumberK113439
Device Name:EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
ClassificationAutoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Applicant EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains,  NJ  07950
ContactKathryn Kohl
CorrespondentKathryn Kohl
EUROIMMUN US 1100 THE AMERICAN ROAD Morris Plains,  NJ  07950
Product CodeNIY  
Subsequent Product CodeDBM
Subsequent Product CodeNBS
Subsequent Product CodeNRI
Subsequent Product CodeNUM
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-21
Decision Date2013-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049016124894 K113439 000
04049016124887 K113439 000

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