510(k) K091522

IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA by Immco Diagnostics, Inc. — Product Code MST

K091522 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA". The FDA issued a decision of Substantially Equivalent on February 4, 2010. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.