510(k) K012795

DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM by Diamedix Corp. — Product Code MST

K012795 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 2001. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Diamedix Corp. has at least 10 other 510(k) clearances on record.