510(k) Report

Devices descending from K972162

4 later devices reach Elecsys CA 125 II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143534Elecsys CA-125 II assayRoche Professional Diagnostics20150—
+1K983875Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc.199911
+1K980240Elecsys CA 125II on the Elecsys 1010Boehringer Mannheim Corp.19980—
+2K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics20220—