510(k) K130053

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI by Bio-Rad Laboratories, Inc. — Product Code MVM

K130053 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI". The FDA issued a decision of Substantially Equivalent on September 19, 2013. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.