510(k) K002189

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM by Scimedx Corp. — Product Code MST

K002189 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Scimedx Corp. has at least 10 other 510(k) clearances on record.