Cleared Traditional

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)

K113439 · Euroimmun US · Immunology
Apr 2013
Decision
508d
Days
Class 2
Risk

About This 510(k) Submission

K113439 is an FDA 510(k) clearance for the EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG), a Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis (Class II — Special Controls, product code NIY), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on April 12, 2013, 508 days after receiving the submission on November 21, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K113439 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date April 12, 2013
Days to Decision 508 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code NIY — Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660
Definition Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis