510(k) K183313

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) by Euroimmun Us, Inc. — Product Code MVM

K183313 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)". The FDA issued a decision of Substantially Equivalent on February 28, 2019. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.