FDA Product Code
FDA Product Code LDJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3870
510(k) Clearances — 150 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. | 2024-01-17 | Traditional | PDF ↗ |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-10 | Traditional | PDF ↗ |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | Healgen Scientific,, LLC | 2023-03-17 | Traditional | PDF ↗ |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-10-11 | Traditional | PDF ↗ |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | Hangzhou Clongene Biotech Co., Ltd. | 2016-03-18 | Traditional | PDF ↗ |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | Nantong Egens Biotech Co., Ltd. | 2015-11-02 | Traditional | PDF ↗ |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | Immunalysis Corporation | 2015-06-05 | Traditional | PDF ↗ |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | Lin-Zhi International, Inc. | 2015-05-28 | Traditional | PDF ↗ |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Polymed Therapeutics, Inc. | 2014-09-25 | Traditional | PDF ↗ |
| K140546 | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST | Healgen Scientific,, LLC | 2014-06-06 | Traditional | PDF ↗ |
| K130213 | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE | Lumiquick Diagnostics, Inc. | 2013-10-18 | Traditional | PDF ↗ |
| K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR | Biophor Diagnostics, Inc. | 2013-10-18 | Traditional | PDF ↗ |
| K122633 | TOXCUP DRUG SCREEN CUP | Branan Medical Corp. | 2013-02-07 | Traditional | PDF ↗ |
| K122759 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) | Omega Laboratories, Inc. | 2012-12-05 | Traditional | PDF ↗ |
| K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2012-07-25 | Traditional | PDF ↗ |
| K111929 | PSYCHEMEDICS CANNABINOIDS EIA | Psychemedics Corp. | 2012-05-01 | Traditional | PDF ↗ |
| K102428 | WUNDER TEST | Hien Helen Nguyen | 2012-04-18 | Traditional | PDF ↗ |
| K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | Lin-Zhi International, Inc. | 2011-06-23 | Traditional | PDF ↗ |
| K110182 | CANNABINOIDS URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-05-20 | Traditional | PDF ↗ |
| K092269 | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET | Randox Laboratories, Ltd. | 2011-04-08 | Traditional | PDF ↗ |
| K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | Microgenics Corp. | 2011-04-08 | Traditional | PDF ↗ |
| K082977 | BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP | Mk Bio, Inc. | 2009-08-20 | Special | PDF ↗ |
| K080467 | BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, | Applied Dna Technologies, Inc. | 2008-11-25 | Traditional | PDF ↗ |
| K080872 | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ | Amedica Biotech, Inc. | 2008-08-19 | Special | PDF ↗ |
| K063164 | VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV | Ortho-Clinical Diagnostics, Inc. | 2006-12-28 | Traditional | PDF ↗ |
| K061556 | AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 | Amedica Biotech, Inc. | 2006-07-21 | Special | PDF ↗ |
| K053034 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 | Acro Biotech, LLC | 2006-06-06 | Traditional | PDF ↗ |
| K050936 | ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE | ACON Laboratories, Inc. | 2005-06-24 | Traditional | PDF ↗ |
| K050878 | ON CALL MULTI-DRUG HOME TEST CUP | ACON Laboratories, Inc. | 2005-06-08 | Traditional | PDF ↗ |
| K050594 | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE | Nano-Ditech Co. | 2005-05-15 | Traditional | PDF ↗ |
| K050050 | ON CALL MULTI-DRUG HOME TEST | ACON Laboratories, Inc. | 2005-03-11 | Traditional | PDF ↗ |
| K041142 | RANDOX CANNABINOIDS ASSSAY | Randox Laboratories, Ltd. | 2004-11-23 | Traditional | PDF ↗ |
| K041221 | ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY | Accu-Stat Diagnostics, Inc. | 2004-07-13 | Traditional | PDF ↗ |
| K040257 | QUEST DIAGNOSTICS HAIRCHECK-DT (THC) | Quest Diagnostics, Inc. | 2004-06-14 | Traditional | PDF ↗ |
| K040464 | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST | Amedica Biotech, Inc. | 2004-05-17 | Traditional | PDF ↗ |
| K040629 | ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE | Accu-Stat Diagnostics, Inc. | 2004-05-05 | Traditional | PDF ↗ |
| K023648 | VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI | Sun Biomedical Laboratories, Inc. | 2003-05-06 | Traditional | PDF ↗ |
| K030213 | ONLINE DAT II CANNABINOIDS II | Roche Diagnostics Corp. | 2003-04-11 | Abbreviated | PDF ↗ |
| K022955 | AMEDICA DRUG SCREEN THC TEST | Amedica Biotech, Inc. | 2002-11-06 | Traditional | PDF ↗ |
| K021887 | CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 | Lin-Zhi International, Inc. | 2002-08-15 | Traditional | PDF ↗ |
| K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC | Princeton BioMeditech Corp. | 2002-06-10 | Traditional | PDF ↗ |
| K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) | Princeton BioMeditech Corp. | 2002-05-23 | Traditional | PDF ↗ |
| K013247 | CANNABINOIDS | Abbott Laboratories | 2002-03-13 | Traditional | PDF ↗ |
| K012390 | NO STEP ON SITE DEUG TEST CUP | Drug Free Enterprises | 2001-12-18 | Traditional | PDF ↗ |
| K011813 | AMEDITECH IMMUTEST DRUG SCREEN THC | Ameditech, Inc. | 2001-10-22 | Traditional | PDF ↗ |
| K012541 | MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET | Branan Medical Corp. | 2001-09-04 | Special | PDF ↗ |
| K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST | Advantage Diagnostics Corp. | 2001-06-25 | Traditional | PDF ↗ |
| K011300 | EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 | Syva Co., Dade Behring, Inc. | 2001-05-17 | Special | PDF ↗ |
| K003557 | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) | ACON Laboratories, Inc. | 2001-03-15 | Traditional | PDF ↗ |
| K010138 | PROFILE II ER | Medtox Diagnostics, Inc. | 2001-02-14 | Special | PDF ↗ |
| K010001 | LIVESURE THC SCREEN TEST | Pan Probe Biotech, Inc. | 2001-02-05 | Traditional | PDF ↗ |
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I | OraSure Technologies, Inc. | 2001-01-26 | Traditional | PDF ↗ |
| K002263 | BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST | Branan Medical Corp. | 2000-11-27 | Traditional | PDF ↗ |
| K001126 | PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST | Alatex Scientific, Inc. | 2000-08-07 | Traditional | PDF ↗ |
| K993663 | FIRST CHECK HOME DRUG TEST (THC) | Worldwide Medical Corp. | 2000-06-23 | Traditional | PDF ↗ |
| K994139 | FIRST CHECK HOME DRUG TEST PANEL 2 | Worldwide Medical Corp. | 2000-06-23 | Traditional | PDF ↗ |
| K994138 | FIRST CHECK HOME DRUG TEST PANEL 3 | Worldwide Medical Corp. | 2000-06-23 | Traditional | PDF ↗ |
| K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2000-06-21 | Traditional | PDF ↗ |
| K001567 | ADVANTAGE THC TEST | Advantage Diagnostics Corp. | 2000-06-19 | Traditional | PDF ↗ |
| K994164 | ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 | Roche Diagnostics Corp. | 2000-04-13 | Traditional | PDF ↗ |
| K000461 | URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A | Dade Behring, Inc. | 2000-04-06 | Traditional | PDF ↗ |
| K000131 | QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 | Phamatech | 2000-02-04 | Special | PDF ↗ |
| K993961 | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) | American Bio Medica Corp. | 2000-01-24 | Traditional | PDF ↗ |
| K993984 | SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL | Syva Co. | 2000-01-18 | Traditional | PDF ↗ |
| K994220 | AT HOME DRUG TEST, MODEL 9078 | Phamatech | 1999-12-30 | Special | PDF ↗ |
| K992949 | SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST | Drug Detection Devices, Ltd. | 1999-12-27 | Traditional | PDF ↗ |
| K993796 | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE | American Bio Medica Corp. | 1999-12-21 | Traditional | PDF ↗ |
| K991516 | MICRO-STRIP FOR MARIJUANA METABOLITES | Microdiagnostics, Inc. | 1999-08-05 | Traditional | PDF ↗ |
| K990818 | RAPIDONE - MARIJUANA TEST | American Bio Medica Corp. | 1999-07-07 | Traditional | PDF ↗ |
| K990870 | REDI-TEST THC | Redwood Biotech, Inc. | 1999-04-27 | Traditional | PDF ↗ |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Roche Diagnostic Systems, Inc. | 1998-12-11 | Special | PDF ↗ |
| K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT | Ameritek, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K973154 | UBI MAGIWEL MARIJUANA METABOLITES | United Biotech, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K980836 | GENIE CUP INTEGRATED SCREENING DEVICE | Applied Technology Ventures, LLC | 1998-06-29 | Traditional | PDF ↗ |
| K981584 | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) | Roche Diagnostic Systems, Inc. | 1998-05-28 | Traditional | PDF ↗ |
| K981585 | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) | Roche Diagnostic Systems, Inc. | 1998-05-28 | Traditional | PDF ↗ |
| K973750 | STC CANNABINOIDS MICRO-PLATE EIA | OraSure Technologies, Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K973122 | QUICKSCREEN ONE STEP THC SCREENING TEST | Phamatech | 1997-09-25 | Traditional | PDF ↗ |
| K970548 | ONE STEP MARIJUANA CARD TEST | Teco Diagnostics | 1997-07-03 | Traditional | PDF ↗ |
| K971841 | BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST | Bionike Laboratories, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K963916 | IMMULITE CANNABINOIDS | Diagnostic Products Corp. | 1997-04-28 | Traditional | PDF ↗ |
| K963654 | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST | Syntron Bioresearch, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K963207 | QUICKPAC II ONE STEP MARIJUANA (THC) TEST | Drial Consultants, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K963516 | VERDICT THC | Editek, Inc. | 1996-10-30 | Traditional | PDF ↗ |
| K963606 | VISUALINE COMBO V (COCAINE/THC) TEST | Sun Biomedical Laboratories, Inc. | 1996-10-30 | Traditional | PDF ↗ |
| K951853 | ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) | Tcpi, Inc. | 1996-08-20 | Traditional | PDF ↗ |
| K955677 | SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT | Beckman Instruments, Inc. | 1996-04-03 | Traditional | PDF ↗ |
| K954497 | FRONTLINE CANNABIS | Boehringer Mannheim Corp. | 1996-03-06 | Traditional | PDF ↗ |
| K950445 | VISUALINE II CANNABINOIDS (THC) | Sun Biomedical Laboratories, Inc. | 1995-05-02 | Traditional | PDF ↗ |
| K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K945550 | ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC | Princeton BioMeditech Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K940158 | EMIT IIC CANNABINOID ASSAY | Syva Co. | 1995-02-22 | Traditional | PDF ↗ |
| K944086 | CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS | Beckman Instruments, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K944088 | CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS | Beckman Instruments, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K943998 | CANNABINOID EIA ASSAY | Diagnostic Reagents, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K944562 | MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION | Microgenics Corp. | 1994-11-02 | Traditional | PDF ↗ |
| K942337 | CEDIA DAU MULTI-LEVEL THC ASSAY | Microgenics Corp. | 1994-08-01 | Traditional | PDF ↗ |
| K940912 | USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 | U.S. Drug Testing, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K940649 | CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT | Microgenics Corp. | 1994-05-17 | Traditional | PDF ↗ |
| K935591 | CEDIA DAU MULTI-LEVEL THC ASSAY | Microgenics Corp. | 1994-01-13 | Traditional | PDF ↗ |
Product code LDJ · Class II · Clinical Toxicology. Data: openFDA.