510(k) Report

Devices descending from K854419

2 later devices reach TDX Cortisol through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983990Vitros Immunodiagnostic Products Cortisol AssayOrtho-Clinical Diagnostics, Inc.19981—
+2K060480Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism…Ortho-Clinical Diagnostics20060—