510(k) K000733

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

K000733 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA". The FDA issued a decision of Substantially Equivalent on May 21, 2001. 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.