Panels › Clinical Toxicology › Product code LDJ · Class 2
Enzyme Immunoassay, Cannabinoids
Regulation 862.3870
0510(k)s in 12 months (150 all time)
0recalls in 12 months (15 all time)
12recalls that name a 510(k)
Top companies in LDJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2024 | K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid M Co-Innovation Biotech Co., Ltd., CN | LDJ |
| Jan 10, 2024 | K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) Hangzhou Laihe Biotech Co., Ltd., CN | LDJ |
| Mar 17, 2023 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT Healgen Scientific,, LLC | LDJ |
| Oct 11, 2019 | K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijua Shenzhen Bioeasy Biotechnology Co., Ltd., CN | LDJ |
| Mar 18, 2016 | K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test Hangzhou Clongene Biotech Co., Ltd., CN | LDJ |
| Nov 2, 2015 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana Nantong Egens Biotech Co., Ltd., CN | LDJ |
| Jun 5, 2015 | K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Se Immunalysis Corporation | LDJ |
| May 28, 2015 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Lin-Zhi International, Inc. | LDJ |
| Sep 25, 2014 | K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip Polymed Therapeutics, Inc. | LDJ |
| Jun 6, 2014 | K140546 | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST Healgen Scientific,, LLC | LDJ |
| Oct 18, 2013 | K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR Biophor Diagnostics, Inc. | LDJ |
| Oct 18, 2013 | K130213 | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE Lumiquick Diagnostics, Inc. | LDJ |
| Feb 7, 2013 | K122633 | TOXCUP DRUG SCREEN CUP Branan Medical Corp. | LDJ |
| Dec 5, 2012 | K122759 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) Omega Laboratories, Inc. | LDJ |
| Jul 25, 2012 | K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LDJ |
| May 1, 2012 | K111929 | PSYCHEMEDICS CANNABINOIDS EIA Psychemedics Corp. | LDJ |
| Apr 18, 2012 | K102428 | WUNDER TEST Hien Helen Nguyen | LDJ |
| Jun 23, 2011 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL Lin-Zhi International, Inc. | LDJ |
| May 20, 2011 | K110182 | CANNABINOIDS URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LDJ |
| Apr 8, 2011 | K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY Microgenics Corp. | LDJ |
| Apr 8, 2011 | K092269 | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET Randox Laboratories, Ltd., GB | LDJ |
| Aug 20, 2009 | K082977 | BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP Mk Bio, Inc. | LDJ |
| Nov 25, 2008 | 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. | LDJ |
| Aug 19, 2008 | K080872 | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ Amedica Biotech, Inc. | LDJ |
| Dec 28, 2006 | K063164 | VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV Ortho-Clinical Diagnostics, Inc. | LDJ |
| Jul 21, 2006 | K061556 | AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 Amedica Biotech, Inc. | LDJ |
| Jun 6, 2006 | K053034 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 Acro Biotech, LLC | LDJ |
| Jun 24, 2005 | K050936 | ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE ACON Laboratories, Inc. | LDJ |
| Jun 8, 2005 | K050878 | ON CALL MULTI-DRUG HOME TEST CUP ACON Laboratories, Inc. | LDJ |
| May 15, 2005 | K050594 | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE Nano-Ditech Co. | LDJ |
| Mar 11, 2005 | K050050 | ON CALL MULTI-DRUG HOME TEST ACON Laboratories, Inc. | LDJ |
| Nov 23, 2004 | K041142 | RANDOX CANNABINOIDS ASSSAY Randox Laboratories, Ltd., GB | LDJ |
| Jul 13, 2004 | K041221 | ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY Accu-Stat Diagnostics, Inc. | LDJ |
| Jun 14, 2004 | K040257 | QUEST DIAGNOSTICS HAIRCHECK-DT (THC) Quest Diagnostics, Inc. | LDJ |
| May 17, 2004 | K040464 | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST Amedica Biotech, Inc. | LDJ |
| May 5, 2004 | K040629 | ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE Accu-Stat Diagnostics, Inc. | LDJ |
| May 6, 2003 | K023648 | VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI Sun Biomedical Laboratories, Inc. | LDJ |
| Apr 11, 2003 | K030213 | ONLINE DAT II CANNABINOIDS II Roche Diagnostics Corp. | LDJ |
| Nov 6, 2002 | K022955 | AMEDICA DRUG SCREEN THC TEST Amedica Biotech, Inc. | LDJ |
| Aug 15, 2002 | K021887 | CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 Lin-Zhi International, Inc. | LDJ |
| Jun 10, 2002 | K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC Princeton BioMeditech Corp. | LDJ |
| May 23, 2002 | K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) Princeton BioMeditech Corp. | LDJ |
| Mar 13, 2002 | K013247 | CANNABINOIDS Abbott Laboratories | LDJ |
| Dec 18, 2001 | K012390 | NO STEP ON SITE DEUG TEST CUP Drug Free Enterprises | LDJ |
| Oct 22, 2001 | K011813 | AMEDITECH IMMUTEST DRUG SCREEN THC Ameditech, Inc. | LDJ |
| Sep 4, 2001 | K012541 | MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET Branan Medical Corp. | LDJ |
| Jun 25, 2001 | K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST Advantage Diagnostics Corp. | LDJ |
| May 17, 2001 | K011300 | EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 Syva Co., Dade Behring, Inc. | LDJ |
| Mar 15, 2001 | K003557 | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) ACON Laboratories, Inc. | LDJ |
| Feb 14, 2001 | K010138 | PROFILE II ER Medtox Diagnostics, Inc. | LDJ |
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