510(k) Report

Devices descending from K951135

5 later devices reach Multi-Drug Control Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040758MGC Dau Control Sets: Primary, Clinical and SelectMicrogenics Corp.20043—
+1K965157Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp.19970—
+2K103656Thermo Scientific Mas R Doa TotalMicrogenics Corporation20110—
+2K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific20091—
+3K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—