Cleared Traditional

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

K112223 · Euroimmun US · Immunology

Sep 2012

Decision

406d

Days

Class 2

Risk

About This 510(k) Submission

K112223 is an FDA 510(k) clearance for the EUROIMMUN ANTI-LKM-1 ELISA(LGG), a Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) (Class II — Special Controls, product code NBS), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on September 11, 2012, 406 days after receiving the submission on August 2, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K112223 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2011
Decision Date	September 11, 2012
Days to Decision	406 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF