510(k) Report

Devices descending from K041322

1 later device reach Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics20230—