510(k) Report

Devices descending from K931780

10 later devices reach Methadone Metabolite Eia Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031797Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. NO. 190 (500 Test Kit), NO. 191…Lin-Zhi International, Inc.20031—
+1K023617Dri Methadone Metabolite Enzyme ImmunoassayMicrogenics Corp.20035—
+1K980746Cedia Dau Eddp AssayBoehringer Mannheim Corp.19982—
+2K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…Lin-Zhi International, Inc.20170—
+2K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…Immunalysis Corporation201531
+2K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—
+2K081378Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsThermo Fisher Scientific20091—
+3K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.20191—
+3K182779ARK EDDP AssayArk Diagnostics, Inc.20180—
+4K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.20200—