510(k) Report

Devices descending from K980746

2 later devices reach Cedia Dau Eddp Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific20091—
+2K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—