Product Code: DIO FDA class 2 21 CFR 862.3250

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Clinical Toxicology

The Enzyme Immunoassay for Cocaine and Cocaine Metabolites is a laboratory test that uses antibody-based enzyme immunoassay technology to screen for the presence of cocaine and its metabolites in biological specimens, commonly used in drug testing and toxicology screening programs. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3250 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

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510(k)s

145

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DIO
Device Class: FDA class 2
Regulation Number: 862.3250
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 145 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213211	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System	Jan 27, 2022	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K211973	DRI Cocaine Metabolite Assay	Sep 24, 2021	Substantially Equivalent	Microgenics Corporation
K191638	Pointe Scientific Cocaine Metabolite Enzyme Immunoassay	Mar 12, 2020	Substantially Equivalent	Medtest DX
K181499	DRI Cocaine Metabolite Assay	Jul 06, 2018	Substantially Equivalent	Microgenics Corporation
K170293	Emit II Plus Cocaine Metabolite Assay	Oct 25, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K163570	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)	Aug 15, 2017	Substantially Equivalent	Carolina Liquid Chemistries Corporation
K162395	MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup	Jun 02, 2017	Substantially Equivalent	Mp Biomedicals, LLC
K152232	Quest Diagnostics HairCheck-DT (Cocaine)	Nov 18, 2016	Substantially Equivalent	Quest Diagnostics Incorporated
K161214	Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)	Jun 27, 2016	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K153646	SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana	Mar 18, 2016	Substantially Equivalent	Safecare Biotech (Hangzhou) Co., Ltd.
K142129	RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET	Jul 24, 2015	Substantially Equivalent	Biophor Diagnostics, Inc.
K150925	Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set	Jun 29, 2015	Substantially Equivalent	Immunalysis Corporation
K142353	First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test	Oct 07, 2014	Substantially Equivalent	W.H.P.M., Inc.
K141647	HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)	Jul 17, 2014	Substantially Equivalent	Healgen Scientific,, LLC
K131128	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES	Nov 13, 2013	Substantially Equivalent	Omega Laboratories, Inc.
K131754	WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)	Jul 31, 2013	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K121166	WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL	May 08, 2012	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K113751	RANDOX COCAINE METABOLITE	May 08, 2012	Substantially Equivalent	Randox Laboratories, Ltd.
K103227	ORATECT ORAL FLUID DRUG SCREEN DEVICES	Apr 11, 2012	Substantially Equivalent	Branan Medical Corporation
K103295	QUICKSCREEN COCAINE 150 SCREENING TEST	Feb 01, 2012	Substantially Equivalent	Phamatech, Inc.
K112808	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES	Jan 23, 2012	Substantially Equivalent	Omega Laboratories, Inc.
K113501	AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)	Dec 05, 2011	Substantially Equivalent	Ameditech, Inc.
K113139	LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS	Nov 22, 2011	Substantially Equivalent	Lin-Zhi International, Inc.
K112071	WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P	Sep 23, 2011	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K101742	THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY	Apr 08, 2011	Substantially Equivalent	Microgenics Corp.
K101160	ROCHE ORAL FLUID COCAINE	Feb 11, 2011	Substantially Equivalent	Roche Diagnostics
K080436	RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052	Feb 11, 2009	Substantially Equivalent	Quantrx Biomedical Corporation
K062929	QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA	Dec 18, 2006	Substantially Equivalent	Quest Diagnostics, Inc.
K062123	VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV	Nov 16, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K053422	RAPIDONE-COCAINE-150 TEST	Jun 15, 2006	Substantially Equivalent	American Bio Medica Corp.
K053035	ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000	May 05, 2006	Substantially Equivalent	Acro Biotech, LLC
K050945	ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS	Mar 29, 2006	Substantially Equivalent	Lin-Zhi International, Inc.
K051578	IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS	Nov 18, 2005	Substantially Equivalent	Immunalysis Corporation
K050465	IMMUNALYSIS COCAINE ELISA FOR HAIR	Aug 04, 2005	Substantially Equivalent	Immunalysis Corporation
K050321	ONTRAK TESTCARD 9	Apr 18, 2005	Substantially Equivalent	Varian, Inc.
K033866	CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)	Apr 07, 2004	Substantially Equivalent	Lin-Zhi International, Inc.
K040198	LABONE COCAINE METABOLITE MICRO-PLATE EIA	Mar 05, 2004	Substantially Equivalent	Labone, Inc.
K032903	ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE	Feb 17, 2004	Substantially Equivalent	ACON Laboratories, Inc.
K033713	URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A	Feb 09, 2004	Substantially Equivalent	Dade Behring, Inc.
K030360	RANDOX EVIDENCE	Dec 23, 2003	Substantially Equivalent	Randox Laboratories, Ltd.
K023626	AML HAIRCHECK-DT (COCAINE)	Sep 29, 2003	Substantially Equivalent	Quest Diagnostics, Inc.
K032057	TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC	Aug 21, 2003	Substantially Equivalent	Branan Medical Corp.
K031512	EMIT II PLUS COCAINE METABOLITE ASSAY	Jul 23, 2003	Substantially Equivalent	Dade Behring, Inc.
K030234	COZART EIA COCAINE ORAL FLIUD KIT	Apr 28, 2003	Substantially Equivalent	Cozart Bioscience , Ltd.
K023489	QUICKTOX MULTIPLE DRUG DIPCARD	Dec 16, 2002	Substantially Equivalent	Branan Medical Corp.
K023281	ONLINE DAT II COCAINE II	Dec 06, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K023296	COBAS INTEGRA ONLINE DAT II COCAINE II	Nov 25, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K022954	AMEDICA DRUG SCREEN COCAINE TEST	Nov 06, 2002	Substantially Equivalent	Amedica Biotech, Inc.
K022355	QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61	Jul 30, 2002	Substantially Equivalent	Branan Medical Corp.
K014069	LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC	Jun 10, 2002	Substantially Equivalent	Princeton BioMeditech Corp.
K014067	LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC	Jun 10, 2002	Substantially Equivalent	Princeton BioMeditech Corp.
K020771	ACON ONE STEP DRUG SCREEN TEST CARD	May 15, 2002	Substantially Equivalent	ACON Laboratories, Inc.
K020763	COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)	May 10, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K020441	EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY	Mar 28, 2002	Substantially Equivalent	Dade Behring, Inc.
K013004	COCAINE	Mar 13, 2002	Substantially Equivalent	Abbott Laboratories
K011814	AMEDITECH IMMUTEST DRUG SCREEN COC	Oct 22, 2001	Substantially Equivalent	Ameditech, Inc.
K011962	ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST	Aug 09, 2001	Substantially Equivalent	Advantage Diagnostics Corp.
K011054	RADS	Jul 30, 2001	Substantially Equivalent	Chason Healthcare, LLC
K010841	ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE	Jul 09, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K010239	COCAINE DIPSTICK TEST, MODEL D747-A	Jun 25, 2001	Substantially Equivalent	Teco Diagnostics
K011162	MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY	May 02, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K010967	LIVESURE COCAINE SCREEN TEST	Apr 17, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K010833	AT WORK DRUG TEST, MODEL 9177T AWT	Apr 11, 2001	Substantially Equivalent	Phamatech
K010650	AT HOME DRUG TEST, MODEL 9073 T	Mar 30, 2001	Substantially Equivalent	Phamatech
K003708	ADVANTAGE THC/COCAINE TEST	Jan 22, 2001	Substantially Equivalent	Advantage Diagnostics Corp.
K002264	BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST	Nov 27, 2000	Substantially Equivalent	Branan Medical Corporation
K994403	INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST	Aug 14, 2000	Substantially Equivalent	Alfa Scientific Designs, Inc.
K994398	INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST	Jul 27, 2000	Substantially Equivalent	Alfa Scientific Designs, Inc.
K001197	COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA	May 11, 2000	Substantially Equivalent	OraSure Technologies, Inc.
K000467	URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A	Apr 14, 2000	Substantially Equivalent	Dade Behring, Inc.
K000350	SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST	Apr 11, 2000	Substantially Equivalent	Drug Detection Devices, Ltd.
K994165	ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595	Apr 07, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K993988	SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL	Jan 27, 2000	Substantially Equivalent	Syva Co.
K994219	AT HOME DRUG TEST, MODEL 9073	Dec 30, 1999	Substantially Equivalent	Phamatech
K993485	VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE	Dec 27, 1999	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K992990	QUICKPAC II ONE STEP COCAINE TEST	Sep 20, 1999	Substantially Equivalent	Syntron Bioresearch, Inc.
K992748	DRUGCHECK X MULTIDRUG SCREENING DEVICE	Sep 02, 1999	Substantially Equivalent	Syntron Bioresearch, Inc.
K991110	REDI-TEST COCAINE	Jul 26, 1999	Substantially Equivalent	Redwood Biotech, Inc.
K992207	QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM	Jul 22, 1999	Substantially Equivalent	Syntron Bioresearch, Inc.
K990822	RAPIDONE - COCAINE TEST	Jul 15, 1999	Substantially Equivalent	American Bio Medica Corp.
K983697	MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE	Dec 11, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K982759	AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U	Nov 20, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K983388	ONTRAK TESTCUP-ER	Nov 18, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K983191	DBEST COCAINE TEST KIT	Nov 18, 1998	Substantially Equivalent	Ameritek, Inc.
K982061	STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)	Aug 25, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K981388	MICRO-STRIP FOR COCAINE METABOLITES	May 29, 1998	Substantially Equivalent	Microdiagnostics, Inc.
K973986	MECTEST	Apr 24, 1998	Substantially Equivalent	Meco Industries
K980153	DRUG CHECK	Mar 27, 1998	Substantially Equivalent	Texas Immunology, Inc.
K980872	RAPID DRUG SCREEN' 8 PANEL	Mar 20, 1998	Substantially Equivalent	American Bio Medica Corp.
K973651	STC COCAINE METABOLITE MICRO-PLATE EIA	Jan 02, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K972059	QUIKPAC II ONE STEP COCAINE TEST	Aug 28, 1997	Substantially Equivalent	Drial Consultants, Inc.
K972384	AQ ONE STEP COCAINE TEST	Aug 06, 1997	Substantially Equivalent	Bionike Laboratories, Inc.
K971926	QUIKSTRIP ONE STEP COCAINE TEST	Jul 14, 1997	Substantially Equivalent	Drial Consultants, Inc.
K964900	RAPID DRUG SCREEN	Apr 14, 1997	Substantially Equivalent	American Bio Medica Corp.
K963918	IMMULITE COCAINE METABOLITE	Apr 08, 1997	Substantially Equivalent	Diagnostic Products Corp.
K962353	ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)	Aug 19, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K960187	COCAINE METABOLITE EIA TEST	Apr 02, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K954496	FRONTLINE COCAINE	Mar 06, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K954571	ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI	Nov 03, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K952361	ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC	Oct 26, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K945549	ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET	Oct 26, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K945207	MECTEST	Sep 25, 1995	Substantially Equivalent	Meco Industries
K951892	ONE STEP URINE DRUG OF ABUSE COCAINE TEST	Aug 17, 1995	Substantially Equivalent	Tcpi, Inc.
K951289	AXSYM COCAINE METABOLITE	Aug 02, 1995	Substantially Equivalent	Abbott Laboratories
K934775	STC COCAINE METABOLITE EIA	Jul 14, 1995	Substantially Equivalent	Solarcare, Inc.
K950369	VISUALINE II COCAINE	Mar 21, 1995	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K945609	ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC	Feb 22, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K935323	EMIT IIC COCAINE METABOLITE ASSAY	Feb 22, 1995	Substantially Equivalent	Syva Co.
K945345	CEDIA DAU COCAINE ASSAY	Jan 17, 1995	Substantially Equivalent	Microgenics Corp.
K944231	ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC	Dec 02, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K944087	CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS	Nov 30, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K943710	VERDICT COCAINE	Nov 17, 1994	Substantially Equivalent	Editek, Inc.
K941310	CEDIA DAU COCAINE ASSAY	Jun 02, 1994	Substantially Equivalent	Microgenics Corp.
K935904	CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS	Mar 11, 1994	Substantially Equivalent	Microgenics Corp.
K935016	COCAINE METABOLITE EIA ASSAY MODIFICATION	Dec 03, 1993	Substantially Equivalent	Diagnostic Reagents, Inc.
K933053	ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF	Aug 30, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K930985	USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100	Apr 27, 1993	Substantially Equivalent	U.S. Drug Testing, Inc.
K921834	AUTOMATES COMA COCAINE METABOLITE ASSAY	Jun 15, 1992	Substantially Equivalent	Serex, Inc.
K915371	COCAINE METABOLITE EIA TEST	Dec 18, 1991	Substantially Equivalent	Diagnostic Reagents, Inc.
K914533	MICRO EIA FOR COCAINE METABOLITES	Dec 10, 1991	Substantially Equivalent	Microdiagnostics, Inc.
K914973	SYVA EMIT D.A.U. COCAINE METABOLITE	Nov 29, 1991	Substantially Equivalent	Syva Co.
K911652	MIRCOLINE SCREEN FOR COCAINE	May 15, 1991	Substantially Equivalent	Drug Screening Systems, Inc.
K902579	EMIT(R) II COCAINE METABOLITE ASSAY	Jul 27, 1990	Substantially Equivalent	Syva Co.
K896781	MICRO DAU COCAINE METABOLITE TEST KIT	Mar 23, 1990	Substantially Equivalent	Immunotech Corp.
K896937	HYCOR ACCUPINCH COCAINE TEST	Mar 06, 1990	Substantially Equivalent	Hycor Biomedical, Inc.
K895043	COMA COCAINE METABOLITE ASSAY (EIA)	Nov 08, 1989	Substantially Equivalent	Serex, Inc.
K890788	ADX COCAINE METABOLITE	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K890883	ABUSCREEN FP BUFFER REAGENT	Mar 15, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K890885	ABUSCREEN FP FOR COCAINE METABOLITE	Mar 13, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K883105	EZ-SCREEN CANNABINOID/COCAINE	Dec 16, 1988	Substantially Equivalent	Environmental Diagnostics, Inc.
K881815	ABUSCREEN(R) ONTRAK(TM) FOR COCAINE	Jul 29, 1988	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K881942	EMIT HVA COCAINE METABOLITE ASSAY	Jul 12, 1988	Substantially Equivalent	Syva Co.
K880009	REVISED LABELING FOR ADX COCAINE METABOLITE	Mar 11, 1988	Substantially Equivalent	Abbott Laboratories
K874487	REVISED LABELING FOR TDX COCAINE METABOLITE	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K874271	REVISED LABELING FOR COCAINE/COCAINE META. TEST	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K874213	ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN	Nov 13, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K874201	REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY	Oct 28, 1987	Substantially Equivalent	Syva Co.
K873752	LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K873751	LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K871305	COCAINE METABOLITE ENZYME IMMUNOASSAY KIT	Jun 05, 1987	Substantially Equivalent	General Diagnostics
K863843	COCAINE METABOLITE ROCHE(R) EIA	Mar 16, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K854163	TDX COCAINE METABOLITE	Nov 05, 1985	Substantially Equivalent	Abbott Laboratories
K843556	EMIT D.A.U. COCAINE ASSAY	Oct 05, 1984	Substantially Equivalent	Syva Co.
K843160	EMIT 700 COCAINE METABOLITE ASSAY	Aug 29, 1984	Substantially Equivalent	Syva Co.
K834549	EMIT ST. URINE COCAINE METABOLITE	Mar 19, 1984	Substantially Equivalent	Syva Co.