510(k) Report

Devices descending from K023617

5 later devices reach Dri Methadone Metabolite Enzyme Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…Immunalysis Corporation201531
+1K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—
+2K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.20191—
+2K182779ARK EDDP AssayArk Diagnostics, Inc.20180—
+3K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.20200—