510(k) K240469

Access TPO Antibody by Beckman Coulter, Inc. — Product Code JZO

K240469 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access TPO Antibody". The FDA issued a decision of Substantially Equivalent on August 9, 2024. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.