510(k) K142133

ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM by Roche Diagnostics — Product Code LFZ

K142133 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM". The FDA issued a decision of Substantially Equivalent on October 24, 2014. 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.