510(k) K161258

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit by Inova Diagnostics, Inc. — Product Code MOB

K161258 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit". The FDA issued a decision of Substantially Equivalent on February 3, 2017. 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.