510(k) K143736

ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA by Immco Diagnostics, Inc. — Product Code DHR

K143736 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA". The FDA issued a decision of Substantially Equivalent on September 23, 2015. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.