510(k) Report

Devices descending from K020662

1 later device reach Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024193Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/CalibratorsOrtho-Clinical Diagnostics20030—