510(k) K213517

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

K213517 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Thyroglobulin Antibody II". The FDA issued a decision of Substantially Equivalent on September 26, 2023. 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.