510(k) Report

Devices descending from K040459

2 later devices reach Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated200715
+2K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated20090—