FDA 510(k) Applications for Medical Device Product Code "DIO"
(Enzyme Immunoassay, Cocaine And Cocaine Metabolites)

FDA 510(k) Number Applicant Device Name Decision Date
K890788 ABBOTT LABORATORIES ADX COCAINE METABOLITE 08/25/1989
K951289 ABBOTT LABORATORIES AXSYM COCAINE METABOLITE 08/02/1995
K013004 ABBOTT LABORATORIES COCAINE 03/13/2002
K880009 ABBOTT LABORATORIES REVISED LABELING FOR ADX COCAINE METABOLITE 03/11/1988
K874487 ABBOTT LABORATORIES REVISED LABELING FOR TDX COCAINE METABOLITE 11/23/1987
K854163 ABBOTT LABORATORIES TDX COCAINE METABOLITE 11/05/1985
K010841 ACON LABORATORIES, INC. ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE 07/09/2001
K032903 ACON LABORATORIES, INC. ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE 02/17/2004
K020771 ACON LABORATORIES, INC. ACON ONE STEP DRUG SCREEN TEST CARD 05/15/2002
K053035 ACRO BIOTECH LLC. ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 05/05/2006
K011962 ADVANTAGE DIAGNOSTICS CORP. ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST 08/09/2001
K003708 ADVANTAGE DIAGNOSTICS CORP. ADVANTAGE THC/COCAINE TEST 01/22/2001
K994398 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST 07/27/2000
K994403 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST 08/14/2000
K022954 AMEDICA BIOTECH, INC. AMEDICA DRUG SCREEN COCAINE TEST 11/06/2002
K113501 AMEDITECH, INC. AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) 12/05/2011
K011814 AMEDITECH, INC. AMEDITECH IMMUTEST DRUG SCREEN COC 10/22/2001
K964900 AMERICAN BIO MEDICA CORP. RAPID DRUG SCREEN 04/14/1997
K980872 AMERICAN BIO MEDICA CORP. RAPID DRUG SCREEN' 8 PANEL 03/20/1998
K990822 AMERICAN BIO MEDICA CORP. RAPIDONE - COCAINE TEST 07/15/1999
K053422 AMERICAN BIO MEDICA CORP. RAPIDONE-COCAINE-150 TEST 06/15/2006
K983191 AMERITEK, INC. DBEST COCAINE TEST KIT 11/18/1998
K944087 BECKMAN INSTRUMENTS, INC. CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS 11/30/1994
K972384 BIONIKE LABORATORIES, INC. AQ ONE STEP COCAINE TEST 08/06/1997
K142129 BIOPHOR DIAGNOSTICS, INC. RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET 07/24/2015
K954496 BOEHRINGER MANNHEIM CORP. FRONTLINE COCAINE 03/06/1996
K023489 BRANAN MEDICAL CORP. QUICKTOX MULTIPLE DRUG DIPCARD 12/16/2002
K022355 BRANAN MEDICAL CORP. QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 07/30/2002
K032057 BRANAN MEDICAL CORP. TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC 08/21/2003
K002264 BRANAN MEDICAL CORPORATION BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST 11/27/2000
K103227 BRANAN MEDICAL CORPORATION ORATECT ORAL FLUID DRUG SCREEN DEVICES 04/11/2012
K163570 Carolina Liquid Chemistries Corporation Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) 08/15/2017
K011054 CHASON HEALTHCARE, LLC. RADS 07/30/2001
K030234 COZART BIOSCIENCE LTD. COZART EIA COCAINE ORAL FLIUD KIT 04/28/2003
K031512 DADE BEHRING, INC. EMIT II PLUS COCAINE METABOLITE ASSAY 07/23/2003
K020441 DADE BEHRING, INC. EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY 03/28/2002
K000467 DADE BEHRING, INC. URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A 04/14/2000
K033713 DADE BEHRING, INC. URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A 02/09/2004
K963918 DIAGNOSTIC PRODUCTS CORP. IMMULITE COCAINE METABOLITE 04/08/1997
K873751 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE 10/15/1987
K873752 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY 10/15/1987
K935016 DIAGNOSTIC REAGENTS, INC. COCAINE METABOLITE EIA ASSAY MODIFICATION 12/03/1993
K915371 DIAGNOSTIC REAGENTS, INC. COCAINE METABOLITE EIA TEST 12/18/1991
K960187 DIAGNOSTIC REAGENTS, INC. COCAINE METABOLITE EIA TEST 04/02/1996
K972059 DRIAL CONSULTANTS, INC. QUIKPAC II ONE STEP COCAINE TEST 08/28/1997
K971926 DRIAL CONSULTANTS, INC. QUIKSTRIP ONE STEP COCAINE TEST 07/14/1997
K000350 DRUG DETECTION DEVICES, LTD. SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST 04/11/2000
K911652 DRUG SCREENING SYSTEMS, INC. MIRCOLINE SCREEN FOR COCAINE 05/15/1991
K874213 E.I. DUPONT DE NEMOURS & CO., INC. ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN 11/13/1987
K943710 EDITEK, INC. VERDICT COCAINE 11/17/1994
K883105 ENVIRONMENTAL DIAGNOSTICS, INC. EZ-SCREEN CANNABINOID/COCAINE 12/16/1988
K871305 GENERAL DIAGNOSTICS COCAINE METABOLITE ENZYME IMMUNOASSAY KIT 06/05/1987
K161214 GUANGZHOU WONDFO BIOTECH CO., LTD. Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) 06/27/2016
K131754 Guangzhou Wondfo Biotech Co., Ltd. WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) 07/31/2013
K112071 Guangzhou Wondfo Biotech Co., Ltd. WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P 09/23/2011
K121166 Guangzhou Wondfo Biotech Co., Ltd. WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL 05/08/2012
K141647 HEALGEN SCIENTIFIC, LLC HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) 07/17/2014
K896937 HYCOR BIOMEDICAL, INC. HYCOR ACCUPINCH COCAINE TEST 03/06/1990
K150925 Immunalysis Corporation Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set 06/29/2015
K050465 Immunalysis Corporation IMMUNALYSIS COCAINE ELISA FOR HAIR 08/04/2005
K051578 Immunalysis Corporation IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS 11/18/2005
K896781 IMMUNOTECH CORP. MICRO DAU COCAINE METABOLITE TEST KIT 03/23/1990
K040198 LABONE, INC. LABONE COCAINE METABOLITE MICRO-PLATE EIA 03/05/2004
K033866 Lin-Zhi International, Inc. CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) 04/07/2004
K020763 Lin-Zhi International, Inc. COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) 05/10/2002
K113139 Lin-Zhi International, Inc. LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS 11/22/2011
K050945 Lin-Zhi International, Inc. ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS 03/29/2006
K973986 MECO INDUSTRIES MECTEST 04/24/1998
K945207 MECO INDUSTRIES MECTEST 09/25/1995
K914533 MICRODIAGNOSTICS, INC. MICRO EIA FOR COCAINE METABOLITES 12/10/1991
K981388 MICRODIAGNOSTICS, INC. MICRO-STRIP FOR COCAINE METABOLITES 05/29/1998
K945345 MICROGENICS CORP. CEDIA DAU COCAINE ASSAY 01/17/1995
K941310 MICROGENICS CORP. CEDIA DAU COCAINE ASSAY 06/02/1994
K935904 MICROGENICS CORP. CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS 03/11/1994
K101742 MICROGENICS CORP. THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY 04/08/2011
K181499 Microgenics Corporation DRI Cocaine Metabolite Assay 07/06/2018
K162395 MP BIOMEDICALS, LLC MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup 06/02/2017
K131128 OMEGA LABORATORIES, INC. OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES 11/13/2013
K112808 OMEGA LABORATORIES, INC. OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES 01/23/2012
K982759 ORASURE TECHNOLOGIES, INC. AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U 11/20/1998
K001197 ORASURE TECHNOLOGIES, INC. COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA 05/11/2000
K973651 ORASURE TECHNOLOGIES, INC. STC COCAINE METABOLITE MICRO-PLATE EIA 01/02/1998
K982061 ORASURE TECHNOLOGIES, INC. STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) 08/25/1998
K062123 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV 11/16/2006
K010967 PAN PROBE BIOTECH, INC. LIVESURE COCAINE SCREEN TEST 04/17/2001
K994219 PHAMATECH AT HOME DRUG TEST, MODEL 9073 12/30/1999
K010650 PHAMATECH AT HOME DRUG TEST, MODEL 9073 T 03/30/2001
K010833 PHAMATECH AT WORK DRUG TEST, MODEL 9177T AWT 04/11/2001
K103295 PHAMATECH INC. QUICKSCREEN COCAINE 150 SCREENING TEST 02/01/2012
K952361 PRINCETON BIOMEDITECH CORP. ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC 10/26/1995
K954571 PRINCETON BIOMEDITECH CORP. ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI 11/03/1995
K945609 PRINCETON BIOMEDITECH CORP. ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC 02/22/1995
K945549 PRINCETON BIOMEDITECH CORP. ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET 10/26/1995
K962353 PRINCETON BIOMEDITECH CORP. ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) 08/19/1996
K014069 PRINCETON BIOMEDITECH CORP. LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC 06/10/2002
K014067 PRINCETON BIOMEDITECH CORP. LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC 06/10/2002
K080436 QUANTRX BIOMEDICAL CORPORATION RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 02/11/2009
K152232 Quest Diagnostics Incorporated Quest Diagnostics HairCheck-DT (Cocaine) 11/18/2016
K023626 QUEST DIAGNOSTICS, INC. AML HAIRCHECK-DT (COCAINE) 09/29/2003
K062929 QUEST DIAGNOSTICS, INC. QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA 12/18/2006
K113751 RANDOX LABORATORIES, LTD. RANDOX COCAINE METABOLITE 05/08/2012
K030360 RANDOX LABORATORIES, LTD. RANDOX EVIDENCE 12/23/2003
K991110 REDWOOD BIOTECH, INC. REDI-TEST COCAINE 07/26/1999
K890883 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP BUFFER REAGENT 03/15/1989
K890885 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR COCAINE METABOLITE 03/13/1989
K933053 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF 08/30/1993
K881815 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(TM) FOR COCAINE 07/29/1988
K863843 ROCHE DIAGNOSTIC SYSTEMS, INC. COCAINE METABOLITE ROCHE(R) EIA 03/16/1987
K983697 ROCHE DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE 12/11/1998
K944231 ROCHE DIAGNOSTIC SYSTEMS, INC. ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC 12/02/1994
K983388 ROCHE DIAGNOSTIC SYSTEMS, INC. ONTRAK TESTCUP-ER 11/18/1998
K874271 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR COCAINE/COCAINE META. TEST 11/13/1987
K101160 Roche Diagnostics ROCHE ORAL FLUID COCAINE 02/11/2011
K023296 ROCHE DIAGNOSTICS CORP. COBAS INTEGRA ONLINE DAT II COCAINE II 11/25/2002
K023281 ROCHE DIAGNOSTICS CORP. ONLINE DAT II COCAINE II 12/06/2002
K994165 ROCHE DIAGNOSTICS CORP. ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 04/07/2000
K153646 SAFECARE BIOTECH (HANGZHOU)CO.,LTD. SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana 03/18/2016
K921834 SEREX, INC. AUTOMATES COMA COCAINE METABOLITE ASSAY 06/15/1992
K895043 SEREX, INC. COMA COCAINE METABOLITE ASSAY (EIA) 11/08/1989
K170293 SIEMENS HEALTHCARE DIAGNOSTICS INC. Emit II Plus Cocaine Metabolite Assay 10/25/2017
K934775 SOLARCARE, INC. STC COCAINE METABOLITE EIA 07/14/1995
K950369 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE II COCAINE 03/21/1995
K993485 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE 12/27/1999
K992748 SYNTRON BIORESEARCH, INC. DRUGCHECK X MULTIDRUG SCREENING DEVICE 09/02/1999
K992990 SYNTRON BIORESEARCH, INC. QUICKPAC II ONE STEP COCAINE TEST 09/20/1999
K992207 SYNTRON BIORESEARCH, INC. QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM 07/22/1999
K843160 SYVA CO. EMIT 700 COCAINE METABOLITE ASSAY 08/29/1984
K843556 SYVA CO. EMIT D.A.U. COCAINE ASSAY 10/05/1984
K881942 SYVA CO. EMIT HVA COCAINE METABOLITE ASSAY 07/12/1988
K935323 SYVA CO. EMIT IIC COCAINE METABOLITE ASSAY 02/22/1995
K834549 SYVA CO. EMIT ST. URINE COCAINE METABOLITE 03/19/1984
K902579 SYVA CO. EMIT(R) II COCAINE METABOLITE ASSAY 07/27/1990
K874201 SYVA CO. REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY 10/28/1987
K914973 SYVA CO. SYVA EMIT D.A.U. COCAINE METABOLITE 11/29/1991
K993988 SYVA CO. SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL 01/27/2000
K011162 SYVA CO., DADE BEHRING, INC. MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY 05/02/2001
K951892 TCPI, INC. ONE STEP URINE DRUG OF ABUSE COCAINE TEST 08/17/1995
K010239 TECO DIAGNOSTICS COCAINE DIPSTICK TEST, MODEL D747-A 06/25/2001
K980153 TEXAS IMMUNOLOGY, INC. DRUG CHECK 03/27/1998
K930985 U.S. DRUG TESTING, INC. USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 04/27/1993
K050321 VARIAN INC ONTRAK TESTCARD 9 04/18/2005
K142353 W.H.P.M., Inc. First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test 10/07/2014


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact