510(k) K163569

Elecsys CMV IgM by Roche Diagnostics — Product Code LFZ

K163569 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys CMV IgM". The FDA issued a decision of Substantially Equivalent on March 17, 2017. 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.