510(k) K091969

EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) by Euroimmun Us, Inc. — Product Code NBO

K091969 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)". The FDA issued a decision of Substantially Equivalent on September 2, 2010. The device falls under product code NBO (Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)), a Class II device regulated under 21 CFR 866.5660. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.