510(k) Report

Devices descending from K053020

10 later devices reach TNL-Ultra Assay for the Advia Centaur System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121790Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay…Beckman Coulter, Inc.201305
+1K121214Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…Beckman Coulter, Inc.201385
+2K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.202504
+2K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.2022018
+2K172787Access hsTnlBeckman Coulter, Inc.201841
+2K172783Access hs TnlBeckman Coulter, Inc.201802
+3K222881Access hsTnIBeckman Coulter, Inc.202301
+3K230648Access hsTnIBeckman Coulter, Inc.202321
+4K243483Access hsTnIBeckman Coulter, Inc.20250—
+4K242870Access hsTnIBeckman Coulter, Inc.20250—