510(k) Report

Devices descending from K043175

3 later devices reach Elecsys Cortisol Test System, Addition of Saliva Sample Type through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070788Elecsys Cortisol Test SystemRoche Diagnostics20072—
+2K152227Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics20161—
+3K202136IDS CortisolImmunodiagnostic Systems, Ltd.20210—