510(k) K152635

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls by Inova Diagnostics, Inc. — Product Code LLL

K152635 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls". The FDA issued a decision of Substantially Equivalent on June 1, 2016. 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.