510(k) K163538

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls by Inova Diagnostics, Inc. — Product Code NBS

K163538 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls". The FDA issued a decision of Substantially Equivalent on September 6, 2017. The device falls under product code NBS (Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)), a Class II device regulated under 21 CFR 866.5660. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.