510(k) K062787

ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 by Phadia US, Inc. — Product Code MVM

K062787 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01". The FDA issued a decision of Substantially Equivalent on December 29, 2006. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Phadia US, Inc. has at least 10 other 510(k) clearances on record.