510(k) Report

Devices descending from K062838

2 later devices reach Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.20250—
+1K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.20240—