510(k) K042579

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT by The Binding Site — Product Code NBT

K042579 is an FDA 510(k) premarket notification submitted by The Binding Site for the device "BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT". The FDA issued a decision of Substantially Equivalent on July 28, 2005. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. The Binding Site has at least 10 other 510(k) clearances on record.