510(k) K131605

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY by Roche Diagnostics — Product Code LFZ

K131605 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on February 28, 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.