510(k) Report

Devices descending from K012208

5 later devices reach Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062516Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)Beckman Coulter, Inc.200642
+2K112933Access Thyroglobulin AnitbodyBeckman Coulter, Inc.201132
+3K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.20250—
+3K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.20231—
+4K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.20240—