FDA 510(k) Applications for Medical Device Product Code "DJR"
(Enzyme Immunoassay, Methadone)

FDA 510(k) Number Applicant Device Name Decision Date
K953499 ABBOTT LABORATORIES AXSYM METHADONE 11/13/1995
K013001 ABBOTT LABORATORIES METHADONE 03/20/2002
K884968 ABBOTT LABORATORIES TDX METHADONE ASSAY 12/16/1988
K012595 ACON LABORATORIES, INC. ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE 10/15/2001
K010015 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW METHADONE URINE CASSETTE TEST 05/29/2001
K010014 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW METHADONE URINE DIP STRIP TEST 05/29/2001
K012164 AMERICAN BIO MEDICA CORP. 'RAPIDONE'-METHADONE TEST 11/20/2001
K023869 AMERICAN BIO MEDICA CORP. 'RAPIDTEC'-5M-MULTIPLE DIP TEST 04/30/2003
K152025 ASSURE TECH. CO., LTD. AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) 10/05/2015
K944074 BECKMAN INSTRUMENTS, INC. CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST 12/02/1994
K973069 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS METHADONE REAGENT 09/22/1997
K911954 BIO-RAD REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION 05/23/1991
K092048 BIOSITE INCORPORATED ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP 04/19/2010
K060791 BIOSITE INCORPORATED TRIAGE TOX DRUG SCREEN, MODEL 94400 06/22/2006
K980746 BOEHRINGER MANNHEIM CORP. CEDIA DAU EDDP ASSAY 05/26/1998
K002417 BRANAN MEDICAL CORPORATION BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D 11/22/2000
K011131 COZART BIOSCIENCE LTD. METHADONE MICROPLATE EIA URINE APPLICATION 07/31/2001
K000466 DADE BEHRING, INC. URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A 04/05/2000
K870937 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT METHADONE TKMD1 03/19/1987
K873750 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGES COAT-A-COUNT METHADONE IN URINE 10/15/1987
K972526 DIAGNOSTIC REAGENTS, INC. METHADONE EIA ASSAY 08/04/1997
K934667 DIAGNOSTIC REAGENTS, INC. METHADONE ENZYME IMMUNOASSAY 01/26/1994
K931780 DIAGNOSTIC REAGENTS, INC. METHADONE METABOLITE EIA ASSAY 08/23/1993
K934147 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK 11/09/1993
K131232 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) 05/31/2013
K023252 ICN BIOMEDICALS, INC. RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 11/22/2002
K151395 Immunalysis Corporation Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets 07/24/2015
K920858 INSTRUMENTATION LABORATORY CO. IL TEST METHADONE 04/24/1992
K170416 Lin-Zhi International, Inc. LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators 06/26/2017
K023317 Lin-Zhi International, Inc. METHADONE ENZYME IMMUNOASSAY 12/12/2002
K031797 Lin-Zhi International, Inc. METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) 10/10/2003
K051058 Lin-Zhi International, Inc. METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS 03/29/2006
K954227 MICROGENICS CORP. CEDIA DAU METHADONE ASSAY 11/17/1995
K023617 MICROGENICS CORP. DRI METHADONE METABOLITE ENZYME IMMUNOASSAY 08/27/2003
K002010 ORASURE TECHNOLOGIES, INC. STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 11/29/2000
K062637 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V 11/22/2006
K013796 PAN PROBE BIOTECH, INC. LIVESURE METHADONE SCREEN TESTS 11/26/2001
K982938 PHAMATECH QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 02/05/1999
K991080 PRINCETON BIOMEDITECH CORP. ACCUSIGN MTD, BIOSIGN MTD 04/15/1999
K962673 PRINCETON BIOMEDITECH CORP. ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY 08/15/1996
K092258 RANDOX LABORATORIES, LTD. RANDOX METABOLITE (EDDP) ASSAY 11/09/2010
K040570 RANDOX LABORATORIES, LTD. RANDOX METHADONE ASSAY 05/10/2004
K092272 RANDOX LABORATORIES, LTD. RANDOX METHADONE ASSAY 11/18/2010
K983703 ROCHE DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE 12/11/1998
K930928 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN ONLINE FOR METHADONE 09/24/1993
K021512 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA ONLINE DAT II METHADONE II 07/16/2002
K021505 ROCHE DIAGNOSTICS CORP. ONLINE DAT II METHADONE II 07/16/2002
K944056 SOLARCARE TECHNOLOGIES CORP,INC. AUTO-LYTE METHADONE DIA 12/29/1994
K981314 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE 09/04/1998
K023856 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE METHADONE DIPSTRIPTEST 08/25/2003
K850953 SYVA CO. EMIT 700 METHADONE ASSAY 04/01/1985
K842676 SYVA CO. EMIT D.A.U. METHADONE ASSAY 09/26/1984
K840060 SYVA CO. EMIT ST URINE METHADONE ASSAY 03/19/1984
K873899 SYVA CO. REVISED LABELING FOR SYVA METHADONE ASSAYS 10/28/1987
K920751 SYVA CO. SYVA EMIT II METHADONE ASSAY 03/13/1992
K994005 SYVA CO. SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL 01/20/2000
K010962 SYVA CO., DADE BEHRING, INC. EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 04/26/2001
K081378 Thermo Fisher Scientific DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS 01/14/2009
K160793 W.H.P.M., INC. First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) 08/17/2016
K151441 W.H.P.M., INC. First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test 06/29/2015
K052197 W.H.P.M., INC. FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST 06/09/2006


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