510(k) Report

Devices descending from K002905

6 later devices reach Access Thyroglobulin Reagents on the Access Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221890Elecsys Tg IIRoche Diagnostics20230—
+1K220972Access ThyroglobulinBeckman Coulter, Inc.20233—
+1K031269Access Thyroglobulin Reagents on the Access Immunoassay SystemsBeckman Coulter, Inc.200306
+2K240927Access ThyroglobulinBeckman Coulter, Inc.20240—
+2K241423Access ThyroglobulinBeckman Coulter, Inc.20241—
+3K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.20250—