510(k) Report

Devices descending from K040437

2 later devices reach Triage Profiler S.O.B. Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042723Trigage Profiler S.O.B. Panel, Model 97300Biosite Incorporated20040—
+1K042890Triage D-Dimer Test, Model 98100Biosite Incorporated20040Class I