510(k) Report

Devices descending from K973650

5 later devices reach Troponin (Trop) Method through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033745Ramp Troponin I AssayResponse Biomedical Corp.20040—
+1K031031Vitros Immunodiagnostic Products Troponin I Reagent Pack and CalibratorsOrtho-Clinical Diagnostics, Inc.200302
+1K020662Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ CalibratorsOrtho-Clinical Diagnostics20021—
+1K992366Vitros Immunodiagnostic Products Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.199902
+2K024193Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/CalibratorsOrtho-Clinical Diagnostics20030—