510(k) K080869

ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC by Beckman Coulter, Inc. — Product Code LGD

K080869 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC". The FDA issued a decision of Substantially Equivalent on May 23, 2008. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.