510(k) Report

Devices descending from K121214

8 later devices reach Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.202504
+1K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.2022018
+1K172787Access hsTnlBeckman Coulter, Inc.201841
+1K172783Access hs TnlBeckman Coulter, Inc.201802
+2K222881Access hsTnIBeckman Coulter, Inc.202301
+2K230648Access hsTnIBeckman Coulter, Inc.202321
+3K243483Access hsTnIBeckman Coulter, Inc.20250—
+3K242870Access hsTnIBeckman Coulter, Inc.20250—