510(k) K220949

Architect CMV IgG by Abbott Laboratories — Product Code LFZ

K220949 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Architect CMV IgG". The FDA issued a decision of Substantially Equivalent on October 27, 2022. 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.