510(k) Report

Devices descending from K954733

3 later devices reach Access Cortisol Assay (Modification) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050202Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc.200521
+2K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.202504
+2K223038Access CortisolBeckman Coulter, Inc.202301