510(k) K993086

AUTOSTAT II ANTI-GLIADIN IGA ELISA by Cogent Diagnotics , Ltd. — Product Code MST

K993086 is an FDA 510(k) premarket notification submitted by Cogent Diagnotics , Ltd. for the device "AUTOSTAT II ANTI-GLIADIN IGA ELISA". The FDA issued a decision of Substantially Equivalent on November 12, 1999. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Cogent Diagnotics , Ltd. has at least 10 other 510(k) clearances on record.