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510(k) K113439

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) by Euroimmun US — Product Code NIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2013
Date Received
November 21, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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

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Other clearances for product code NIY

  • K112221 — EUROIMMUN ANTI-SLA/LP ELISA(LGG) (September 11, 2012)
  • K021482 — QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA (July 30, 2002)