510(k) Report

Devices descending from K102086

2 later devices reach Elecsys CA 125 II Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143534Elecsys CA-125 II assayRoche Professional Diagnostics20150—
+1K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—