510(k) K113863

QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS by Inova Diagnostics, Inc. — Product Code MST

K113863 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS". The FDA issued a decision of Substantially Equivalent on September 20, 2012. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.