510(k) DEN000007

QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA by Inova Diagnostics, Inc. — Product Code NBT

DEN000007 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA". The FDA issued a decision of De Novo Granted on August 16, 2000. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.