Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)

Q: What is the product code of K113439?

The FDA product code is NIY – Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis, a Class II (moderate risk) device regulated under 21 CFR 866.5660.

FDA 510(k) K113439 · Euroimmun US

Substantially Equivalent

510(k) numberK113439

Submission

Device name: Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)
Applicant: Euroimmun US
Morris Plains, NJ, US
Received: November 21, 2011
Decision date: April 12, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NIY – Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5660
Specialty: Immunology

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

Other 510(k)s with product code NIY

510(k)	Device	Applicant	Decision
K112221	Euroimmun Anti-Sla/Lp Elisa(Lgg)NIY · Traditional	Euroimmun US	09/11/2012SE
K021482	Quanta Lite Sla (Soluble Liver Antigen) ElisaNIY · Traditional	Inova Diagnostics, Inc.	07/30/2002SE

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Questions and answers

When was Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) cleared by the FDA?

Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) (K113439) received a 510(k) decision of Substantially Equivalent on April 12, 2013, 508 days after the submission was received.

What is the product code of K113439?

The FDA product code is NIY – Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis, a Class II (moderate risk) device regulated under 21 CFR 866.5660.