510(k) Report

Devices descending from K040758

3 later devices reach MGC Dau Control Sets: Primary, Clinical and Select through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103656Thermo Scientific Mas R Doa TotalMicrogenics Corporation20110—
+1K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific20091—
+2K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—