EUROIMMUN ANTI-SLA/LP ELISA(LGG)

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 Anti-sla/lp Elisa(lgg).

Pre-market Notification Details

Device IDK112221
510k NumberK112221
Device Name:EUROIMMUN ANTI-SLA/LP ELISA(LGG)
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  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-02
Decision Date2012-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049016026785 K112221 000

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