FDA 510(k) Applications for Medical Device Product Code "DIS"
(Enzyme Immunoassay, Barbiturate)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K012996 | ABBOTT LABORATORIES | BARBITURATES | 03/20/2002 |
| 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 |
| K990280 | BIONIKE, INC. | BIONIKE AQ BARBITURATE TEST | 06/28/1999 |
| K002337 | BRANAN MEDICAL CORPORATION | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST | 11/22/2000 |
| 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 |
| K955928 | DIAGNOSTIC REAGENTS, INC. | BARBITURATE EIA ESSAY (MODIFICATION) | 03/11/1996 |
| 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 |
| K963529 | EDITEK, INC. | VERDICT BARBITURATES | 10/30/1996 |
| 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 |
| 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 |
| K010959 | MEDTOX DIAGNOSTICS, INC. | VERDICT -II BAR; VERDICT -II BZO | 04/13/2001 |
| K010561 | MEDTOX DIAGNOSTICS, INC. | VERDICT -II BAR/BZO | 04/05/2001 |
| 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 |
| K962669 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY | 08/15/1996 |
| K991018 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR | 04/15/1999 |
| 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 |
| K983698 | ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | 05/03/1999 |
| 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 |
| 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 |
| 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 |
| K010934 | SYVA CO., DADE BEHRING, INC. | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 | 04/20/2001 |
| K110515 | UCP BIOSCIENCES, INC. | UCP DRUG SCREENING TEST CUPS | 04/20/2011 |
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