510(k) Report

Devices descending from K992349

4 later devices reach Vitros Immunodiagnostic Products Troponin I Range Verifiers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062838Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Ortho-Clinical Diagnostics200622
+1K033300Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersOrtho-Clinical Diagnostics, Inc.200301
+2K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.20250—
+2K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.20240—