510(k) K073501

ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG by Roche Diagnostics Corp. — Product Code LGD

K073501 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG". The FDA issued a decision of Substantially Equivalent on June 9, 2008. 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 Corp. has at least 10 other 510(k) clearances on record.