510(k) K041102

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA by Immco Diagnostics, Inc. — Product Code LJM

K041102 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA". The FDA issued a decision of Substantially Equivalent on October 26, 2004. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.