510(k) Report

Devices descending from K062516

4 later devices reach Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112933Access Thyroglobulin AnitbodyBeckman Coulter, Inc.201132
+2K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.20250—
+2K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.20231—
+3K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.20240—