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DJR — Enzyme Immunoassay, Methadone Class II

FDA Device Classification

Classification Details

Product Code
DJR
Device Class
Class II
Regulation Number
862.3620
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192433lin-zhi internationalLZI Methadone II Enzyme ImmunoassayOctober 4, 2019
K182779ark diagnosticsARK EDDP AssayNovember 21, 2018
K170416lin-zhi internationalLZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3June 26, 2017
K160793w.h.p.mFirst Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign DAugust 17, 2016
K152025assure tech. coAssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)October 5, 2015
K151395immunalysis corporationImmunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine CalibJuly 24, 2015
K151441w.h.p.mFirst Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestJune 29, 2015
K131232guangzhou wondfo biotech coWONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)May 31, 2013
K092272randox laboratoriesRANDOX METHADONE ASSAYNovember 18, 2010
K092258randox laboratoriesRANDOX METABOLITE (EDDP) ASSAYNovember 9, 2010
K092048biosite incorporatedONE STEP EDDP (METHADONE METABOLITE) TEST STRIPApril 19, 2010
K081378thermo fisher scientificDRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLSJanuary 14, 2009
K062637ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERINovember 22, 2006
K060791biosite incorporatedTRIAGE TOX DRUG SCREEN, MODEL 94400June 22, 2006
K052197w.h.p.mFIRST SIGN DRUG OF ABUSE URINE SCREENING TESTJune 9, 2006
K051058lin-zhi internationalMETHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLSMarch 29, 2006
K040570randox laboratoriesRANDOX METHADONE ASSAYMay 10, 2004
K031797lin-zhi internationalMETHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO.October 10, 2003
K023617microgenicsDRI METHADONE METABOLITE ENZYME IMMUNOASSAYAugust 27, 2003
K023856sun biomedical laboratoriesVISUALINE METHADONE DIPSTRIPTESTAugust 25, 2003