FDA 510(k) Applications for Medical Device Product Code "LDJ"
(Enzyme Immunoassay, Cannabinoids)

FDA 510(k) Number Applicant Device Name Decision Date
K890693 ABBOTT LABORATORIES ADX CANNABINOIDS 08/25/1989
K013247 ABBOTT LABORATORIES CANNABINOIDS 03/13/2002
K904541 ABBOTT LABORATORIES LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS 11/20/1990
K880015 ABBOTT LABORATORIES REVISED LABELING FOR ADX CANNABINOIDS 03/01/1988
K874488 ABBOTT LABORATORIES REVISED LABELING FOR TDX CANNABINOIDS 11/23/1987
K883731 ABBOTT LABORATORIES TDX CANNABINOIDS-GS 10/11/1988
K864751 ABBOTT LABORATORIES TDXR CANNABINOIDS 03/13/1987
K874646 ABBOTT LABORATORIES TDXR DELTA-9-CANNABINOIDS 12/18/1987
K041221 ACCU-STAT DIAGNOSTICS, INC. ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY 07/13/2004
K040629 ACCU-STAT DIAGNOSTICS, INC. ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE 05/05/2004
K003557 ACON LABORATORIES, INC. ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) 03/15/2001
K050936 ACON LABORATORIES, INC. ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE 06/24/2005
K050050 ACON LABORATORIES, INC. ON CALL MULTI-DRUG HOME TEST 03/11/2005
K050878 ACON LABORATORIES, INC. ON CALL MULTI-DRUG HOME TEST CUP 06/08/2005
K053034 ACRO BIOTECH LLC. ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 06/06/2006
K010921 ADVANTAGE DIAGNOSTICS CORP. ADVANTAGE MARIJUANA (THC) HOME DRUG TEST 06/25/2001
K001567 ADVANTAGE DIAGNOSTICS CORP. ADVANTAGE THC TEST 06/19/2000
K001126 ALATEX SCIENTIFIC, INC. PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST 08/07/2000
K994410 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST 06/21/2000
K022955 AMEDICA BIOTECH, INC. AMEDICA DRUG SCREEN THC TEST 11/06/2002
K061556 AMEDICA BIOTECH, INC. AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 07/21/2006
K040464 AMEDICA BIOTECH, INC. AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST 05/17/2004
K080872 AMEDICA BIOTECH, INC. AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ 08/19/2008
K011813 AMEDITECH, INC. AMEDITECH IMMUTEST DRUG SCREEN THC 10/22/2001
K993961 AMERICAN BIO MEDICA CORP. RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) 01/24/2000
K993796 AMERICAN BIO MEDICA CORP. RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE 12/21/1999
K990818 AMERICAN BIO MEDICA CORP. RAPIDONE - MARIJUANA TEST 07/07/1999
K983188 AMERITEK, INC. DBEST TETRAHYDROCANNABINOL TEST KIT 11/18/1998
K080467 APPLIED DNA TECHNOLOGIES, INC. BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, 11/25/2008
K980836 APPLIED TECHNOLOGY VENTURES, L.L.C. GENIE CUP INTEGRATED SCREENING DEVICE 06/29/1998
K944088 BECKMAN INSTRUMENTS, INC. CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS 11/21/1994
K944086 BECKMAN INSTRUMENTS, INC. CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS 12/29/1994
K955677 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT 04/03/1996
K971841 BIONIKE LABORATORIES, INC. BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST 06/25/1997
K132096 BIOPHOR DIAGNOSTICS, INC. RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR 10/18/2013
K931598 BIOSITE INCORPORATED BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML) 05/12/1993
K954497 BOEHRINGER MANNHEIM CORP. FRONTLINE CANNABIS 03/06/1996
K002263 BRANAN MEDICAL CORP. BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST 11/27/2000
K012541 BRANAN MEDICAL CORP. MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET 09/04/2001
K122633 BRANAN MEDICAL CORP. TOXCUP DRUG SCREEN CUP 02/07/2013
K000461 DADE BEHRING, INC. URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A 04/06/2000
K871695 DIAGNOSTIC PRODUCTS CORP. DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5 06/05/1987
K963916 DIAGNOSTIC PRODUCTS CORP. IMMULITE CANNABINOIDS 04/28/1997
K873753 DIAGNOSTIC PRODUCTS CORP. LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE 10/15/1987
K901568 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) CANNABINOIDS 05/17/1990
K943998 DIAGNOSTIC REAGENTS, INC. CANNABINOID EIA ASSAY 11/04/1994
K920311 DIAGNOSTIC REAGENTS, INC. CANNABINOID EIA TEST 02/27/1992
K963207 DRIAL CONSULTANTS, INC. QUICKPAC II ONE STEP MARIJUANA (THC) TEST 02/20/1997
K992949 DRUG DETECTION DEVICES, LTD. SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST 12/27/1999
K012390 DRUG FREE ENTERPRISES NO STEP ON SITE DEUG TEST CUP 12/18/2001
K914915 DRUG SCREENING SYSTEMS, INC. MICROLINE SCREEN FOR CANNABINOID 01/22/1992
K875252 E.I. DUPONT DE NEMOURS & CO., INC. ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH 02/03/1988
K950181 E.I. DUPONT DE NEMOURS & CO., INC. URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE 04/05/1995
K963516 EDITEK, INC. VERDICT THC 10/30/1996
K872882 GENERAL DIAGNOSTICS CANNABINOID ENZYME IMMUNOASSAY KIT 11/03/1987
K110182 Guangzhou Wondfo Biotech Co., Ltd. CANNABINOIDS URINE TEST 05/20/2011
K121557 Guangzhou Wondfo Biotech Co., Ltd. WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST 07/25/2012
K153741 HANGZHOU CLONGENE BIOTECH CO., LTD. CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test 03/18/2016
K140546 HEALGEN SCIENTIFIC, LLC HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST 06/06/2014
K102428 HIEN HELEN NGUYEN WUNDER TEST 04/18/2012
K151203 IMMUNALYSIS CORPORATION Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set 06/05/2015
K904635 IMMUNOTECH CORP. MICROZYME THC ENZYME IMMUNOASSAY TEST KIT 11/01/1990
K920418 INSTRUMENTATION LABORATORY CO. IL TEST CANNABINOID, 35282 02/27/1992
K870197 KEYSTONE DIAGNOSTICS, INC. KDI QUIK TEST(TM) MARIJUANA SCREEN 06/01/1987
K875219 KEYSTONE DIAGNOSTICS, INC. MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN 06/24/1988
K021887 Lin-Zhi International, Inc. CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 08/15/2002
K110239 Lin-Zhi International, Inc. LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL 06/23/2011
K141320 Lin-Zhi International, Inc. LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls 05/28/2015
K130213 LUMIQUICK DIAGNOSTICS, INC. QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE 10/18/2013
K010138 MEDTOX DIAGNOSTICS, INC. PROFILE II ER 02/14/2001
K914490 MICRODIAGNOSTICS, INC. MICRO EIA FOR MARIJUANA METABOLITES 11/29/1991
K991516 MICRODIAGNOSTICS, INC. MICRO-STRIP FOR MARIJUANA METABOLITES 08/05/1999
K935591 MICROGENICS CORP. CEDIA DAU MULTI-LEVEL THC ASSAY 01/13/1994
K942337 MICROGENICS CORP. CEDIA DAU MULTI-LEVEL THC ASSAY 08/01/1994
K940649 MICROGENICS CORP. CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT 05/17/1994
K944562 MICROGENICS CORP. MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION 11/02/1994
K101744 MICROGENICS CORP. THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY 04/08/2011
K082977 MK BIO, INC BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP 08/20/2009
K050594 NANO-DITECH CO. NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE 05/15/2005
K152643 NANTONG EGENS BIOTECH CO., LTD. EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana 11/02/2015
K122759 OMEGA LABORATORIES, INC. OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) 12/05/2012
K002375 ORASURE TECHNOLOGIES, INC. STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I 01/26/2001
K973750 ORASURE TECHNOLOGIES, INC. STC CANNABINOIDS MICRO-PLATE EIA 02/13/1998
K063164 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV 12/28/2006
K010001 PAN PROBE BIOTECH, INC. LIVESURE THC SCREEN TEST 02/05/2001
K994220 PHAMATECH AT HOME DRUG TEST, MODEL 9078 12/30/1999
K973122 PHAMATECH QUICKSCREEN ONE STEP THC SCREENING TEST 09/25/1997
K000131 PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 02/04/2000
K142408 POLYMED THERAPEUTICS, INC FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) 09/25/2014
K945550 PRINCETON BIOMEDITECH CORP. ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC 02/22/1995
K014193 PRINCETON BIOMEDITECH CORP. LIFESIGN DOA 4 (THC/OPI/COC/MET) 05/23/2002
K014066 PRINCETON BIOMEDITECH CORP. LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC 06/10/2002
K111929 PSYCHEMEDICS CORP. PSYCHEMEDICS CANNABINOIDS EIA 05/01/2012
K040257 QUEST DIAGNOSTICS, INC. QUEST DIAGNOSTICS HAIRCHECK-DT (THC) 06/14/2004
K092269 RANDOX LABORATORIES, LTD. CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET 04/08/2011
K041142 RANDOX LABORATORIES, LTD. RANDOX CANNABINOIDS ASSSAY 11/23/2004
K990870 REDWOOD BIOTECH, INC. REDI-TEST THC 04/27/1999
K870377 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN (R) EIA CANNABINOIDS 03/16/1987
K890887 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR CANNABINOIDS 03/16/1989
K910592 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR CANNABINOIDS (15-50) 06/21/1991
K910589 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN FP FOR CANNABINOIDS (50-100) 04/03/1991
K981584 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) 05/28/1998
K981585 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) 05/28/1998
K904856 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONTRAK FOR THC 12/13/1990
K912757 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS 07/26/1991
K881814 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(TM) FOR THC 07/29/1988
K983701 ROCHE DIAGNOSTIC SYSTEMS, INC. MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS 12/11/1998
K874269 ROCHE DIAGNOSTIC SYSTEMS, INC. REVISED LABELING FOR CANNABINOIDS TEST KIT 11/20/1987
K030213 ROCHE DIAGNOSTICS CORP. ONLINE DAT II CANNABINOIDS II 04/11/2003
K994164 ROCHE DIAGNOSTICS CORP. ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 04/13/2000
K874390 SAKERS, INC. "CRACK-IT" CANNABINOID SCREEN 04/10/1989
K924815 SOLARCARE TECHNOLOGIES CORP,INC. MICROPLATE CANNABINOIDS ASSAY 01/26/1993
K930654 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA 05/06/1993
K882362 STAT PATH STAT FIX MICROWAVE IRRADIATION MEDIUM 06/22/1988
K963606 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE COMBO V (COCAINE/THC) TEST 10/30/1996
K023648 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI 05/06/2003
K950445 SUN BIOMEDICAL LABORATORIES, INC. VISUALINE II CANNABINOIDS (THC) 05/02/1995
K963654 SYNTRON BIORESEARCH, INC. QUIKSTRIP ONESTEP MARIJUANA (THC) TEST 02/28/1997
K851373 SYVA CO. EMIT 700 CANNABINOID 20 ASSAY 05/01/1985
K843421 SYVA CO. EMIT 700 CANNABINOID ASSAY 09/25/1984
K860500 SYVA CO. EMIT D.A.U. CANNABINOID 20NG ASSAY 04/11/1986
K882313 SYVA CO. EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS 08/29/1988
K834458 SYVA CO. EMIT D.A.U. URINE CANNABINOID ASSAY 06/21/1984
K882819 SYVA CO. EMIT HVA CANNABINOID 100 NG ASSAY 08/08/1988
K940158 SYVA CO. EMIT IIC CANNABINOID ASSAY 02/22/1995
K841238 SYVA CO. EMIT ST URINE CANNABINOID ASSAY 06/21/1984
K904568 SYVA CO. EMIT(R) II CANNABINOID 100 NG ASSAY 12/26/1990
K904570 SYVA CO. EMIT(R) II CANNABINOID 20 NG ASSAY 12/26/1990
K904571 SYVA CO. EMIT(R) II CANNABINOID 50 NG ASSAY 12/26/1990
K932716 SYVA CO. EMIT(R) THC 50/100 NG ASSAY 10/01/1993
K812195 SYVA CO. EMIT-ST CANNABINOID ASSAY 08/20/1981
K833580 SYVA CO. MODIF. OF EMIT URINE CANNABINOID 01/26/1984
K874079 SYVA CO. REVISED LABELING FOR SYVA CANNABINOID ASSAYS 10/28/1987
K874156 SYVA CO. STICKER LABEL FOR DRUGS OF ABUSE ASSAYS 10/28/1987
K993984 SYVA CO. SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL 01/18/2000
K011300 SYVA CO., DADE BEHRING, INC. EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 05/17/2001
K951853 TCPI, INC. ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) 08/20/1996
K970548 TECO DIAGNOSTICS ONE STEP MARIJUANA CARD TEST 07/03/1997
K940912 U.S. DRUG TESTING, INC. USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 06/02/1994
K973154 UNITED BIOTECH, INC. UBI MAGIWEL MARIJUANA METABOLITES 07/22/1998
K910893 V-TECH, INC. TARGET(TM) CANNABINOIDS-R TEST 04/03/1991
K910892 V-TECH, INC. TARGET(TM) CANNABINOIDS-V TEST 04/03/1991
K993663 WORLDWIDE MEDICAL CORP. FIRST CHECK HOME DRUG TEST (THC) 06/23/2000
K994139 WORLDWIDE MEDICAL CORP. FIRST CHECK HOME DRUG TEST PANEL 2 06/23/2000
K994138 WORLDWIDE MEDICAL CORP. FIRST CHECK HOME DRUG TEST PANEL 3 06/23/2000


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