510(k) K181871

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay by Phadia AB — Product Code MVM

K181871 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay". The FDA issued a decision of Substantially Equivalent on March 1, 2019. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Phadia AB has at least 10 other 510(k) clearances on record.