510(k) Report

Devices descending from K990943

2 later devices reach Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041322Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersOrtho-Clinical Diagnostics, Inc.20041—
+2K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics20230—