Product Code: LDJ FDA class 2 21 CFR 862.3870

Enzyme Immunoassay, Cannabinoids

Clinical Toxicology

Enzyme immunoassay for cannabinoids is a laboratory test system using antibody-based detection to identify and quantify cannabinoid compounds (primarily THC and its metabolites) in patient specimens, used for drug screening or monitoring in clinical toxicology settings. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LDJ, regulated under 21 CFR 862.3870, in the Clinical Toxicology specialty. Third-party review eligibility applies.

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510(k)s

150

FEI Numbers

103

Registration Numbers

103

Unique Applicants

Years Active

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Basic Information

Product Code: LDJ
Device Class: FDA class 2
Regulation Number: 862.3870
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 150 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
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	Jan 17, 2024	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.
K232604	LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)	Jan 10, 2024	Substantially Equivalent	Hangzhou Laihe Biotech Co., Ltd.
K223162	Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT	Mar 17, 2023	Substantially Equivalent	Healgen Scientific,, LLC
K192515	BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20	Oct 11, 2019	Substantially Equivalent	Shenzhen Bioeasy Biotechnology Co., Ltd.
K153741	CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test	Mar 18, 2016	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.
K152643	EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana	Nov 02, 2015	Substantially Equivalent	Nantong Egens Biotech Co., Ltd.
K151203	Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set	Jun 05, 2015	Substantially Equivalent	Immunalysis Corporation
K141320	LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls	May 28, 2015	Substantially Equivalent	Lin-Zhi International, Inc.
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)	Sep 25, 2014	Substantially Equivalent	Polymed Therapeutics, Inc.
K140546	HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST	Jun 06, 2014	Substantially Equivalent	Healgen Scientific,, LLC
K132096	RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR	Oct 18, 2013	Substantially Equivalent	Biophor Diagnostics, Inc.
K130213	QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE	Oct 18, 2013	Substantially Equivalent	Lumiquick Diagnostics, Inc.
K122633	TOXCUP DRUG SCREEN CUP	Feb 07, 2013	Substantially Equivalent	Branan Medical Corp.
K122759	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)	Dec 05, 2012	Substantially Equivalent	Omega Laboratories, Inc.
K121557	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	Jul 25, 2012	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K111929	PSYCHEMEDICS CANNABINOIDS EIA	May 01, 2012	Substantially Equivalent	Psychemedics Corp.
K102428	WUNDER TEST	Apr 18, 2012	Substantially Equivalent	Hien Helen Nguyen
K110239	LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL	Jun 23, 2011	Substantially Equivalent	Lin-Zhi International, Inc.
K110182	CANNABINOIDS URINE TEST	May 20, 2011	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K101744	THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY	Apr 08, 2011	Substantially Equivalent	Microgenics Corp.
K092269	CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET	Apr 08, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K082977	BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP	Aug 20, 2009	Substantially Equivalent	Mk Bio, Inc.
K080467	BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,	Nov 25, 2008	Substantially Equivalent	Applied Dna Technologies, Inc.
K080872	AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ	Aug 19, 2008	Substantially Equivalent	Amedica Biotech, Inc.
K063164	VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV	Dec 28, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K061556	AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020	Jul 21, 2006	Substantially Equivalent	Amedica Biotech, Inc.
K053034	ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000	Jun 06, 2006	Substantially Equivalent	Acro Biotech, LLC
K050936	ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE	Jun 24, 2005	Substantially Equivalent	ACON Laboratories, Inc.
K050878	ON CALL MULTI-DRUG HOME TEST CUP	Jun 08, 2005	Substantially Equivalent	ACON Laboratories, Inc.
K050594	NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE	May 15, 2005	Substantially Equivalent	Nano-Ditech Co.
K050050	ON CALL MULTI-DRUG HOME TEST	Mar 11, 2005	Substantially Equivalent	ACON Laboratories, Inc.
K041142	RANDOX CANNABINOIDS ASSSAY	Nov 23, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K041221	ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY	Jul 13, 2004	Substantially Equivalent	Accu-Stat Diagnostics, Inc.
K040257	QUEST DIAGNOSTICS HAIRCHECK-DT (THC)	Jun 14, 2004	Substantially Equivalent	Quest Diagnostics, Inc.
K040464	AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST	May 17, 2004	Substantially Equivalent	Amedica Biotech, Inc.
K040629	ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE	May 05, 2004	Substantially Equivalent	Accu-Stat Diagnostics, Inc.
K023648	VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI	May 06, 2003	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K030213	ONLINE DAT II CANNABINOIDS II	Apr 11, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K022955	AMEDICA DRUG SCREEN THC TEST	Nov 06, 2002	Substantially Equivalent	Amedica Biotech, Inc.
K021887	CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071	Aug 15, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K014066	LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC	Jun 10, 2002	Substantially Equivalent	Princeton BioMeditech Corp.
K014193	LIFESIGN DOA 4 (THC/OPI/COC/MET)	May 23, 2002	Substantially Equivalent	Princeton BioMeditech Corp.
K013247	CANNABINOIDS	Mar 13, 2002	Substantially Equivalent	Abbott Laboratories
K012390	NO STEP ON SITE DEUG TEST CUP	Dec 18, 2001	Substantially Equivalent	Drug Free Enterprises
K011813	AMEDITECH IMMUTEST DRUG SCREEN THC	Oct 22, 2001	Substantially Equivalent	Ameditech, Inc.
K012541	MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET	Sep 04, 2001	Substantially Equivalent	Branan Medical Corp.
K010921	ADVANTAGE MARIJUANA (THC) HOME DRUG TEST	Jun 25, 2001	Substantially Equivalent	Advantage Diagnostics Corp.
K011300	EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229	May 17, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K003557	ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)	Mar 15, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K010138	PROFILE II ER	Feb 14, 2001	Substantially Equivalent	Medtox Diagnostics, Inc.
K010001	LIVESURE THC SCREEN TEST	Feb 05, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K002375	STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I	Jan 26, 2001	Substantially Equivalent	OraSure Technologies, Inc.
K002263	BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST	Nov 27, 2000	Substantially Equivalent	Branan Medical Corp.
K001126	PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST	Aug 07, 2000	Substantially Equivalent	Alatex Scientific, Inc.
K994139	FIRST CHECK HOME DRUG TEST PANEL 2	Jun 23, 2000	Substantially Equivalent	Worldwide Medical Corp.
K994138	FIRST CHECK HOME DRUG TEST PANEL 3	Jun 23, 2000	Substantially Equivalent	Worldwide Medical Corp.
K993663	FIRST CHECK HOME DRUG TEST (THC)	Jun 23, 2000	Substantially Equivalent	Worldwide Medical Corp.
K994410	INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST	Jun 21, 2000	Substantially Equivalent	Alfa Scientific Designs, Inc.
K001567	ADVANTAGE THC TEST	Jun 19, 2000	Substantially Equivalent	Advantage Diagnostics Corp.
K994164	ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579	Apr 13, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000461	URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A	Apr 06, 2000	Substantially Equivalent	Dade Behring, Inc.
K000131	QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04	Feb 04, 2000	Substantially Equivalent	Phamatech
K993961	RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)	Jan 24, 2000	Substantially Equivalent	American Bio Medica Corp.
K993984	SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL	Jan 18, 2000	Substantially Equivalent	Syva Co.
K994220	AT HOME DRUG TEST, MODEL 9078	Dec 30, 1999	Substantially Equivalent	Phamatech
K992949	SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST	Dec 27, 1999	Substantially Equivalent	Drug Detection Devices, Ltd.
K993796	RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE	Dec 21, 1999	Substantially Equivalent	American Bio Medica Corp.
K991516	MICRO-STRIP FOR MARIJUANA METABOLITES	Aug 05, 1999	Substantially Equivalent	Microdiagnostics, Inc.
K990818	RAPIDONE - MARIJUANA TEST	Jul 07, 1999	Substantially Equivalent	American Bio Medica Corp.
K990870	REDI-TEST THC	Apr 27, 1999	Substantially Equivalent	Redwood Biotech, Inc.
K983701	MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS	Dec 11, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K983188	DBEST TETRAHYDROCANNABINOL TEST KIT	Nov 18, 1998	Substantially Equivalent	Ameritek, Inc.
K973154	UBI MAGIWEL MARIJUANA METABOLITES	Jul 22, 1998	Substantially Equivalent	United Biotech, Inc.
K980836	GENIE CUP INTEGRATED SCREENING DEVICE	Jun 29, 1998	Substantially Equivalent	Applied Technology Ventures, LLC
K981585	ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)	May 28, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981584	ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)	May 28, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K973750	STC CANNABINOIDS MICRO-PLATE EIA	Feb 13, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K973122	QUICKSCREEN ONE STEP THC SCREENING TEST	Sep 25, 1997	Substantially Equivalent	Phamatech
K970548	ONE STEP MARIJUANA CARD TEST	Jul 03, 1997	Substantially Equivalent	Teco Diagnostics
K971841	BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST	Jun 25, 1997	Substantially Equivalent	Bionike Laboratories, Inc.
K963916	IMMULITE CANNABINOIDS	Apr 28, 1997	Substantially Equivalent	Diagnostic Products Corp.
K963654	QUIKSTRIP ONESTEP MARIJUANA (THC) TEST	Feb 28, 1997	Substantially Equivalent	Syntron Bioresearch, Inc.
K963207	QUICKPAC II ONE STEP MARIJUANA (THC) TEST	Feb 20, 1997	Substantially Equivalent	Drial Consultants, Inc.
K963606	VISUALINE COMBO V (COCAINE/THC) TEST	Oct 30, 1996	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K963516	VERDICT THC	Oct 30, 1996	Substantially Equivalent	Editek, Inc.
K951853	ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)	Aug 20, 1996	Substantially Equivalent	Tcpi, Inc.
K955677	SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT	Apr 03, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K954497	FRONTLINE CANNABIS	Mar 06, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K950445	VISUALINE II CANNABINOIDS (THC)	May 02, 1995	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K950181	URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE	Apr 05, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K945550	ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC	Feb 22, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K940158	EMIT IIC CANNABINOID ASSAY	Feb 22, 1995	Substantially Equivalent	Syva Co.
K944086	CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS	Dec 29, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K944088	CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS	Nov 21, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K943998	CANNABINOID EIA ASSAY	Nov 04, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K944562	MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION	Nov 02, 1994	Substantially Equivalent	Microgenics Corp.
K942337	CEDIA DAU MULTI-LEVEL THC ASSAY	Aug 01, 1994	Substantially Equivalent	Microgenics Corp.
K940912	USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500	Jun 02, 1994	Substantially Equivalent	U.S. Drug Testing, Inc.
K940649	CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT	May 17, 1994	Substantially Equivalent	Microgenics Corp.
K935591	CEDIA DAU MULTI-LEVEL THC ASSAY	Jan 13, 1994	Substantially Equivalent	Microgenics Corp.
K932716	EMIT(R) THC 50/100 NG ASSAY	Oct 01, 1993	Substantially Equivalent	Syva Co.
K931598	BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)	May 12, 1993	Substantially Equivalent	Biosite Incorporated
K930654	STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA	May 06, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K924815	MICROPLATE CANNABINOIDS ASSAY	Jan 26, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K920418	IL TEST CANNABINOID, 35282	Feb 27, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K920311	CANNABINOID EIA TEST	Feb 27, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K914915	MICROLINE SCREEN FOR CANNABINOID	Jan 22, 1992	Substantially Equivalent	Drug Screening Systems, Inc.
K914490	MICRO EIA FOR MARIJUANA METABOLITES	Nov 29, 1991	Substantially Equivalent	Microdiagnostics, Inc.
K912757	ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS	Jul 26, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910592	ABUSCREEN FP FOR CANNABINOIDS (15-50)	Jun 21, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910893	TARGET(TM) CANNABINOIDS-R TEST	Apr 03, 1991	Substantially Equivalent	V-Tech, Inc.
K910892	TARGET(TM) CANNABINOIDS-V TEST	Apr 03, 1991	Substantially Equivalent	V-Tech, Inc.
K910589	ABUSCREEN FP FOR CANNABINOIDS (50-100)	Apr 03, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K904571	EMIT(R) II CANNABINOID 50 NG ASSAY	Dec 26, 1990	Substantially Equivalent	Syva Co.
K904570	EMIT(R) II CANNABINOID 20 NG ASSAY	Dec 26, 1990	Substantially Equivalent	Syva Co.
K904568	EMIT(R) II CANNABINOID 100 NG ASSAY	Dec 26, 1990	Substantially Equivalent	Syva Co.
K904856	ABUSCREEN ONTRAK FOR THC	Dec 13, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K904541	LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS	Nov 20, 1990	Substantially Equivalent	Abbott Laboratories
K904635	MICROZYME THC ENZYME IMMUNOASSAY TEST KIT	Nov 01, 1990	Substantially Equivalent	Immunotech Corp.
K901568	MILENIA(TM) CANNABINOIDS	May 17, 1990	Substantially Equivalent	Diagnostic Products Corp.
K901334	HYCOR ACCUPINCH THC TEST	May 14, 1990	Substantially Equivalent	Hycor Biomedical, Inc.
K890693	ADX CANNABINOIDS	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K874390	CRACK-IT CANNABINOID SCREEN	Apr 10, 1989	Substantially Equivalent	Sakers, Inc.
K890887	ABUSCREEN FP FOR CANNABINOIDS	Mar 16, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K883731	TDX CANNABINOIDS-GS	Oct 11, 1988	Substantially Equivalent	Abbott Laboratories
K882313	EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS	Aug 29, 1988	Substantially Equivalent	Syva Co.
K882819	EMIT HVA CANNABINOID 100 NG ASSAY	Aug 08, 1988	Substantially Equivalent	Syva Co.
K881814	ABUSCREEN(R) ONTRAK(TM) FOR THC	Jul 29, 1988	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K875219	MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN	Jun 24, 1988	Substantially Equivalent	Keystone Diagnostics, Inc.
K882362	STAT FIX MICROWAVE IRRADIATION MEDIUM	Jun 22, 1988	Substantially Equivalent	Stat Path
K880015	REVISED LABELING FOR ADX CANNABINOIDS	Mar 01, 1988	Substantially Equivalent	Abbott Laboratories
K875252	ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH	Feb 03, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K874646	TDXR DELTA-9-CANNABINOIDS	Dec 18, 1987	Substantially Equivalent	Abbott Laboratories
K874488	REVISED LABELING FOR TDX CANNABINOIDS	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K874269	REVISED LABELING FOR CANNABINOIDS TEST KIT	Nov 20, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K872882	CANNABINOID ENZYME IMMUNOASSAY KIT	Nov 03, 1987	Substantially Equivalent	General Diagnostics
K874156	STICKER LABEL FOR DRUGS OF ABUSE ASSAYS	Oct 28, 1987	Substantially Equivalent	Syva Co.
K874079	REVISED LABELING FOR SYVA CANNABINOID ASSAYS	Oct 28, 1987	Substantially Equivalent	Syva Co.
K873753	LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K871695	DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5	Jun 05, 1987	Substantially Equivalent	Diagnostic Products Corp.
K870197	KDI QUIK TEST(TM) MARIJUANA SCREEN	Jun 01, 1987	Substantially Equivalent	Keystone Diagnostics, Inc.
K870377	ABUSCREEN (R) EIA CANNABINOIDS	Mar 16, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K864751	TDXR CANNABINOIDS	Mar 13, 1987	Substantially Equivalent	Abbott Laboratories
K860500	EMIT D.A.U. CANNABINOID 20NG ASSAY	Apr 11, 1986	Substantially Equivalent	Syva Co.
K851373	EMIT 700 CANNABINOID 20 ASSAY	May 01, 1985	Substantially Equivalent	Syva Co.
K843421	EMIT 700 CANNABINOID ASSAY	Sep 25, 1984	Substantially Equivalent	Syva Co.
K841238	EMIT ST URINE CANNABINOID ASSAY	Jun 21, 1984	Substantially Equivalent	Syva Co.
K834458	EMIT D.A.U. URINE CANNABINOID ASSAY	Jun 21, 1984	Substantially Equivalent	Syva Co.
K833580	MODIF. OF EMIT URINE CANNABINOID	Jan 26, 1984	Substantially Equivalent	Syva Co.
K812195	EMIT-ST CANNABINOID ASSAY	Aug 20, 1981	Substantially Equivalent	Syva Co.