510(k) K112545

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM by Inova Diagnostics, Inc. — Product Code MOB

K112545 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM". The FDA issued a decision of Substantially Equivalent on July 31, 2012. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.