510(k) Report

Devices descending from K974461

4 later devices reach Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030089Triage Cardiac Controls; Triage Cardio Profiler ControlsBiosite Incorporated20033—
+2K040459Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsBiosite Incorporated20042—
+3K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated200715
+4K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated20090—