510(k) K152013

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls by Inova Diagnostics, Inc. — Product Code LSW

K152013 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls". The FDA issued a decision of Substantially Equivalent on April 11, 2016. The device falls under product code LSW (Anti-Dna 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.