Quanta Lite Sla (Soluble Liver Antigen) Elisa

Q: What is the product code of K021482?

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) K021482 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK021482

Submission

Device name: Quanta Lite Sla (Soluble Liver Antigen) Elisa
Applicant: Inova Diagnostics, Inc.
San Diego, CA, US
Received: May 8, 2002
Decision date: July 30, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K113439	Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)NIY · Traditional	Euroimmun US	04/12/2013SE
K112221	Euroimmun Anti-Sla/Lp Elisa(Lgg)NIY · Traditional	Euroimmun US	09/11/2012SE

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Questions and answers

When was Quanta Lite Sla (Soluble Liver Antigen) Elisa cleared by the FDA?

Quanta Lite Sla (Soluble Liver Antigen) Elisa (K021482) received a 510(k) decision of Substantially Equivalent on July 30, 2002, 83 days after the submission was received.

What is the product code of K021482?

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.