510(k) K242095

Access Toxo IgM II by Beckman Coulter, Inc. — Product Code LGD

K242095 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Toxo IgM II". The FDA issued a decision of Substantially Equivalent on October 11, 2024. 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.