510(k) K062708

QUANTA LITE CELIAC DGP SCREEN by Inova Diagnostics, Inc. — Product Code MST

K062708 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE CELIAC DGP SCREEN". The FDA issued a decision of Substantially Equivalent on December 13, 2006. 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.