510(k) Report

Devices descending from K003967

3 later devices reach CA 125 II Calcheck through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102086Elecsys CA 125 II Calcheck 5Roche Diagnostics20102—
+2K143534Elecsys CA-125 II assayRoche Professional Diagnostics20150—
+2K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—