510(k) Report

Devices descending from K030089

3 later devices reach Triage Cardiac Controls; Triage Cardio Profiler Controls through their predicates, nearest generation first.

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