510(k) K132234

LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II by DiaSorin, Inc. — Product Code LGD

K132234 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II". The FDA issued a decision of Substantially Equivalent on August 28, 2013. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.