510(k) K043433

AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA by Hycor Biomedical , Ltd. — Product Code MVM

K043433 is an FDA 510(k) premarket notification submitted by Hycor Biomedical , Ltd. for the device "AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA". The FDA issued a decision of Substantially Equivalent on March 7, 2005. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Hycor Biomedical , Ltd. has at least 10 other 510(k) clearances on record.