FDA 510(k) Applications for Medical Device Product Code "LDJ"
(Enzyme Immunoassay, Cannabinoids)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013247 | ABBOTT LABORATORIES | CANNABINOIDS | 03/13/2002 |
| 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 |
| 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 |
| 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 |
| K963916 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE CANNABINOIDS | 04/28/1997 |
| 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 |
| K963516 | EDITEK, INC. | VERDICT THC | 10/30/1996 |
| 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 |
| K223162 | Healgen Scientific LLC | Healgen« Accurate Oral Fluid Drug Test, Healgen« Accurate Oral Fluid Drug Test COT | 03/17/2023 |
| 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 |
| 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 |
| K991516 | MICRODIAGNOSTICS, INC. | MICRO-STRIP FOR MARIJUANA METABOLITES | 08/05/1999 |
| 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 |
| 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 |
| 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 |
| K983701 | ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | 12/11/1998 |
| 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 |
| K192515 | Shenzhen Bioeasy Biotechnology Co.,Ltd. | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | 10/11/2019 |
| 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 |
| K963654 | SYNTRON BIORESEARCH, INC. | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST | 02/28/1997 |
| 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 |
| K973154 | UNITED BIOTECH, INC. | UBI MAGIWEL MARIJUANA METABOLITES | 07/22/1998 |
| 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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