510(k) K052499

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS by Diasorin S.P.A — Product Code LGD

K052499 is an FDA 510(k) premarket notification submitted by Diasorin S.P.A for the device "DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS". The FDA issued a decision of Substantially Equivalent on February 8, 2006. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Diasorin S.P.A has at least 10 other 510(k) clearances on record.