Euroimmun ANTI-LKM-1 Elisa(Lgg)

Q: What is the product code of K112223?

The FDA product code is NBS – Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1), a Class II (moderate risk) device regulated under 21 CFR 866.5660.

FDA 510(k) K112223 · Euroimmun US

Substantially Equivalent

510(k) numberK112223

Submission

Device name: Euroimmun ANTI-LKM-1 Elisa(Lgg)
Applicant: Euroimmun US
Morris Plains, NJ, US
Received: August 2, 2011
Decision date: September 11, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NBS – Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5660
Specialty: Immunology

Other 510(k)s with product code NBS

510(k)	Device	Applicant	Decision
K163538	QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1…NBS · Traditional	Inova Diagnostics, Inc.	09/06/2017SE
K000535	Quanta Lite LKM-1 ElisaNBS · Traditional	Inova Diagnostics, Inc.	06/07/2000SE

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Questions and answers

When was Euroimmun ANTI-LKM-1 Elisa(Lgg) cleared by the FDA?

Euroimmun ANTI-LKM-1 Elisa(Lgg) (K112223) received a 510(k) decision of Substantially Equivalent on September 11, 2012, 406 days after the submission was received.

What is the product code of K112223?

The FDA product code is NBS – Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1), a Class II (moderate risk) device regulated under 21 CFR 866.5660.