510(k) Report

Devices descending from K983875

1 later device reach Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics20220—