510(k) Report

Devices descending from K011323

6 later devices reach High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102841Pantex AM/PM Salivary Cortisol Enzyme ImmunoassayPantex, Div. Bio-Analysis, Inc.20121—
+1K043175Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp.200431
+2K150528Cortisol Saliva Luminescence ImmunoassayIbl International GmbH201501
+2K070788Elecsys Cortisol Test SystemRoche Diagnostics20072—
+3K152227Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics20161—
+4K202136IDS CortisolImmunodiagnostic Systems, Ltd.20210—