FDA 510(k) Applications for Medical Device Product Code "DJR"
(Enzyme Immunoassay, Methadone)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013001 | ABBOTT LABORATORIES | METHADONE | 03/20/2002 |
| 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 |
| K182779 | ARK Diagnostics, Inc. | ARK EDDP Assay | 11/21/2018 |
| 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 |
| K973069 | BECKMAN INSTRUMENTS, INC. | SYNCHRON SYSTEMS METHADONE REAGENT | 09/22/1997 |
| 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 |
| K972526 | DIAGNOSTIC REAGENTS, INC. | METHADONE EIA ASSAY | 08/04/1997 |
| 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 |
| K192433 | Lin-Zhi International, Inc | LZI Methadone II Enzyme Immunoassay | 10/04/2019 |
| 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 |
| 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 |
| K962673 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY | 08/15/1996 |
| K991080 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN MTD, BIOSIGN MTD | 04/15/1999 |
| 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 |
| 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 |
| 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 |
| 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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