510(k) K032850

IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) by Immco Diagnostics, Inc. — Product Code NBT

K032850 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)". The FDA issued a decision of Substantially Equivalent on March 18, 2004. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.