510(k) Report

Devices descending from K153651

1 later device reach Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.2022018