510(k) K062583

ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 by Phadia US, Inc. — Product Code MVM

K062583 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01". The FDA issued a decision of Substantially Equivalent on December 26, 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.