510(k) K111414

QUANTA FLASH (TM) DGP SCREEN by Inova Diagnostics, Inc. — Product Code MST

K111414 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA FLASH (TM) DGP SCREEN". The FDA issued a decision of Substantially Equivalent on October 20, 2011. 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.