Cleared Traditional

EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)

K091969 · Euroimmun Us, Inc. · Immunology

Sep 2010

Decision

428d

Days

Class 2

Risk

About This 510(k) Submission

K091969 is an FDA 510(k) clearance for the EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG), a Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) (Class II — Special Controls, product code NBO), submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on September 2, 2010, 428 days after receiving the submission on July 1, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K091969 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2009
Decision Date	September 02, 2010
Days to Decision	428 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF