510(k) K062516

ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) by Beckman Coulter, Inc. — Product Code JNL

K062516 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)". The FDA issued a decision of Substantially Equivalent on October 5, 2006. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.