510(k) K063775

ELIA GLIADIN IGA, IGG AND CELIAC CONTROL by Phadia US, Inc. — Product Code MST

K063775 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA GLIADIN IGA, IGG AND CELIAC CONTROL". The FDA issued a decision of Substantially Equivalent on March 14, 2007. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Phadia US, Inc. has at least 10 other 510(k) clearances on record.