510(k) K953943

AXSYM CMV IGG ANTIBODY ASSAY by Abbott Laboratories — Product Code LFZ

K953943 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM CMV IGG ANTIBODY ASSAY". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Abbott Laboratories has at least 10 other 510(k) clearances on record.