510(k) K071692

THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS by Theratest Laboratories, Inc. — Product Code MVM

K071692 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 5, 2007. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.