510(k) Report

Devices descending from K973517

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063720Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range VerifiersOrtho-Clinical Diagnostics200711
+1K992349Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc.19994—
+1K990984Vitros Immunodiagnostic Products Cea Range VerifiersOrtho-Clinical Diagnostics, Inc.19993—
+1K990783Vitros Immunodiagnostic Products CA15-3 Range Verifiers, CA125 II Range Verifiers, Psa…Ortho-Clinical Diagnostics, Inc.19990—
+1K990026Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc.19991—
+1K990061Vitros Immunodiagnostic Products Afp Range VerifiersOrtho-Clinical Diagnostics, Inc.19990—
+1K984011Vitros Immunodiagnostic Products Cortisol Range VerifiersOrtho-Clinical Diagnostics, Inc.19980—
+1K983513Vitros Immunodiagnostic Products Range VerifiersOrtho-Clinical Diagnostics, Inc.19980—
+2K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics20240—
+2K062838Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Ortho-Clinical Diagnostics200622
+2K060632Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range Verifiers,680…Ortho-Clinical Diagnostics, Inc.200602
+2K041322Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersOrtho-Clinical Diagnostics, Inc.20041—
+2K033300Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersOrtho-Clinical Diagnostics, Inc.200301
+2K013900Vitros Immunodiagnostic Products Vitamin B12 Range VerifiersOrtho-Clinical Diagnostics20010—
+3K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.20250—
+3K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.20240—
+3K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics20230—