510(k) K220911

Elecsys CMV IgG by Roche Diagnostics — Product Code LFZ

K220911 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys CMV IgG". The FDA issued a decision of Substantially Equivalent on October 12, 2022. The device falls under product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Roche Diagnostics has at least 10 other 510(k) clearances on record.