510(k) K162678

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl by Roche Diagnostics — Product Code LGD

K162678 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl". The FDA issued a decision of Substantially Equivalent on June 23, 2017. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Roche Diagnostics has at least 10 other 510(k) clearances on record.