510(k) K141328

QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS by Inova Diagnostics, Inc. — Product Code LLL

K141328 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS". The FDA issued a decision of Substantially Equivalent on February 12, 2015. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.