510(k) Report

Devices descending from K974075

3 later devices reach Access Troponin I Reagents on the Access Immunoassay Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062838Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Ortho-Clinical Diagnostics200622
+2K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.20250—
+2K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.20240—