FDA 510(k) Applications for Medical Device Product Code "DIS"
(Enzyme Immunoassay, Barbiturate)

FDA 510(k) Number Applicant Device Name Decision Date
K890690 ABBOTT LABORATORIES ADX TM BARBITURATES 08/25/1989
K951253 ABBOTT LABORATORIES AXSYM BARBITURATES II U 05/18/1995
K012996 ABBOTT LABORATORIES BARBITURATES 03/20/2002
K880012 ABBOTT LABORATORIES REVISED LABELING FOR ADX BARBITURATES 03/01/1988
K874483 ABBOTT LABORATORIES REVISED LABELING FOR TDX BARBITURATES 11/23/1987
K892650 ABBOTT LABORATORIES TDX BARBITURATES SERUM 05/16/1989
K896550 ABBOTT LABORATORIES TDX(R) BARBITURATES II ASSAY 12/19/1989
K050593 ACON LABORATORIES, INC. ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE 05/06/2005
K012824 ACON LABORATORIES, INC. ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE 11/09/2001
K023946 ACON LABORATORIES, INC. ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE 02/05/2003
K010125 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST 05/29/2001
K003647 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW BARBITURATE URINE CASSETTE TEST 05/29/2001
K042975 AMEDITECH, INC. AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II 12/29/2004
K041712 AMERICAN BIO MEDICA CORP. 'RAPIDTEC 4' TEST 11/03/2004
K992451 AMERICAN BIO MEDICA CORP. RAPIDONE- BARBITURATE TEST 04/03/2000
K151211 Assure Tech. Co., Ltd AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup 06/04/2015
K944075 BECKMAN INSTRUMENTS, INC. CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST 12/29/1994
K990280 BIONIKE, INC. BIONIKE AQ BARBITURATE TEST 06/28/1999
K920525 BIOTRACK, INC. BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL 08/05/1992
K002337 BRANAN MEDICAL CORPORATION BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST 11/22/2000
K953021 CIBA CORNING DIAGNOSTICS CORP. ACS PHENOBARBITAL 12/11/1995
K140215 CO-INNOVATION BIOTECH CO., LTD. ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD 06/16/2014
K000459 DADE BEHRING, INC. URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A 04/03/2000
K870936 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5 03/19/1987
K873754 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE BARBITURATES IN URINE 10/15/1987
K955928 DIAGNOSTIC REAGENTS, INC. BARBITURATE EIA ESSAY (MODIFICATION) 03/11/1996
K925491 DIAGNOSTIC REAGENTS, INC. BARBITURATE EIA TEST 12/30/1992
K960664 DIAGNOSTIC REAGENTS, INC. BARBITURATE SERUM TOX EIA ASSAY 05/06/1996
K973047 DRIAL CONSULTANTS, INC. ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST 10/02/1997
K000522 DRUG DETECTION DEVICES, LTD. SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST 04/18/2000
K933480 DRUG SCREENING SYSTEMS, INC. MICROLINE SCREEN FOR BARBITURATES 10/29/1993
K842783 E.I. DUPONT DE NEMOURS & CO., INC. ACA BARBITURATES SCREEN ANALY TEST PACK 09/07/1984
K873623 E.I. DUPONT DE NEMOURS & CO., INC. ACA URINE BARBITURATES SCREEN METHOD 10/20/1987
K950137 E.I. DUPONT DE NEMOURS & CO., INC. URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE 04/13/1995
K963529 EDITEK, INC. VERDICT BARBITURATES 10/30/1996
K905057 ENVIRONMENTAL DIAGNOSTICS, INC. EZ-SCREEN:BARBITURATES 11/28/1990
K882663 GENERAL DIAGNOSTICS BARBITURATE ENZYME IMMUNOASSAY KIT 09/19/1988
K864993 GENERAL DIAGNOSTICS QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE 03/31/1987
K140665 GENPRIME, INC GenPrime Snap-Top Split Key Cup 12/08/2014
K143535 GUANGZHOU WONDFO BIOTECH CO., LTD. CR3 Keyless Split Sample Cup Secobarbital- Methadone 01/13/2015
K050024 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS 11/17/2005
K150791 HEALGEN SCIENTIFIC LLC Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) 04/24/2015
K161714 IMMUNALYSIS CORPORATION Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators 10/14/2016
K920417 INSTRUMENTATION LABORATORY CO. IL TEST BARBITURATE, 35289 04/24/1992
K032764 Lin-Zhi International, Inc. BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) 11/03/2003
K033885 Lin-Zhi International, Inc. BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) 05/19/2004
K033334 MEDTOX DIAGNOSTICS, INC. PROFILE -ER 11/10/2003
K002331 MEDTOX DIAGNOSTICS, INC. PROFILE-ER 01/17/2001
K010561 MEDTOX DIAGNOSTICS, INC. VERDICT -II BAR/BZO 04/05/2001
K010959 MEDTOX DIAGNOSTICS, INC. VERDICT -II BAR; VERDICT -II BZO 04/13/2001
K936030 MICROGENICS CORP. CEDIA DAU BARBITURATE ASSAY 03/22/1994
K942436 MICROGENICS CORP. CEDIA DAU BARBITURATE ASSAY 08/30/1994
K945344 MICROGENICS CORP. CEDIA DAU BARBITURATE ASSAY 12/28/1994
K942404 MICROGENICS CORP. CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION 07/28/1994
K982745 ORASURE TECHNOLOGIES, INC. AUTO-LYTE BARBITURATES EIA 11/18/1998
K001976 ORASURE TECHNOLOGIES, INC. STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I 12/06/2000
K062165 ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS 01/05/2007
K012133 PAN PROBE BIOTECH, INC. LIVESURE BARBITURATES SCREEN TEST 07/20/2001
K982152 PHAMATECH QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 09/21/1998
K070009 PHAMATECH INC. AT HOME DRUG TEST MODELS, 9308T AND 9308X 12/07/2007
K070098 PHAMATECH INC. QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC 12/07/2007
K991018 PRINCETON BIOMEDITECH CORP. ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR 04/15/1999
K962669 PRINCETON BIOMEDITECH CORP. ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY 08/15/1996
K961010 PRINCETON BIOMEDITECH CORP. ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD 06/28/1996
K991082 PRINCETON BIOMEDITECH CORP. ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO 04/15/1999
K991084 PRINCETON BIOMEDITECH CORP. ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD 04/15/1999
K991076 PRINCETON BIOMEDITECH CORP. ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP 04/15/1999
K041143 RANDOX LABORATORIES, LTD. RANDOX BARBITURATE ASSAY 11/05/2004
K092268 RANDOX LABORATORIES, LTD. RANDOX BARITURATES ASSAY 05/25/2011
K870378 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN (R) EIA BARBITURATE 03/16/1987
K890884 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR BARBITURATES 03/09/1989
K983698 ROCHE DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO ABUSCREEN ONLINE BARBITURATES 05/03/1999
K874210 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR ABUSCREEN EIA BARBITURATE 11/13/1987
K874266 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR BARBITURATE TEST KIT 11/13/1987
K982551 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN 08/18/1998
K043211 ROCHE DIAGNOSTICS CORP. ONLINE DAT BARBITURATES PLUS 12/29/2004
K991440 ROCHE DIAGNOSTICS CORP. ROCHE COBAS INTEGRA SERUM BARBITURATES 06/22/1999
K941489 SCHIAPPARELLI BIOSYSTEMS, INC. ACE CLINICAL CHEMISTRY SYSTEM 07/18/1994
K934376 SOLARCARE, INC. STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA 12/07/1993
K020136 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE BARBITURATES DIPSTRIP TEST 03/20/2002
K014089 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES 04/25/2002
K920314 SYNTEX CORP. TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) 04/17/1992
K980349 SYNTRON BIORESEARCH, INC. QUICKPAC II ONE STEP BARBITURATE TEST 03/03/1998
K974712 SYNTRON BIORESEARCH, INC. QUIKSTRIP ONE STEP BARBITURATE TEST 02/12/1998
K843418 SYVA CO. EMIT 700 BARBITURATE ASSAY 09/14/1984
K842675 SYVA CO. EMIT D.A.U. BARBITURATE ASSAY 09/26/1984
K882611 SYVA CO. EMIT HVA BARBITURATE ASSAY 08/08/1988
K935116 SYVA CO. EMIT IIC BARBITURATE ASSAY 02/22/1995
K840194 SYVA CO. EMIT ST SERUM BARBITURATE ASSAY 03/19/1984
K931535 SYVA CO. EMIT(R) D.A.U. BARBITURATE ASSAY 06/15/1993
K902580 SYVA CO. EMIT(R) II BARBITURATE ASSAY 07/19/1990
K926068 SYVA CO. EMIT(R) II BARBITURATE ASSAY 01/12/1993
K792114 SYVA CO. EMIT-BARBITURATE ASSAY 12/04/1979
K810602 SYVA CO. EMIT-ST SERUM BARBITURATE ASSAY 04/03/1981
K802617 SYVA CO. EMIT-STM BARBITURATE ASSAY 10/31/1980
K833577 SYVA CO. MODIF. OF EMIT URINE BARBITURATE 01/26/1984
K874702 SYVA CO. REVISED LABELING FOR SYVA BARBITURATE ASSAYS 01/05/1988
K010934 SYVA CO., DADE BEHRING, INC. EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 04/20/2001
K903825 TECHNICON INSTRUMENTS CORP. DRUG OF ABUSE ANALYSIS SYSTEM 09/27/1990
K110515 UCP BIOSCIENCES, INC. UCP DRUG SCREENING TEST CUPS 04/20/2011


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