Product Code: DIF FDA class 1 21 CFR 862.3280

Drug Mixture Control Materials

Clinical Toxicology

The Drug Mixture Control Materials are reference standards used in clinical toxicology laboratories to verify the accuracy and performance of drug testing assays by providing known concentrations of multiple drug analytes in a single sample. This device is classified as FDA Class 1, indicating low risk, subject only to general controls without premarket notification. It is regulated under 21 CFR 862.3280 within the Clinical Toxicology specialty.

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510(k)s

202

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DIF
Device Class: FDA class 1
Regulation Number: 862.3280
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 4

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 202 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K153474	Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series	Feb 23, 2016	Substantially Equivalent	Biochemical Diagnostics, Inc.
K132688	SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ	Dec 16, 2013	Substantially Equivalent	Biochemical Diagnostics, Inc.
K132174	MULTICHEM WBT	Sep 20, 2013	Substantially Equivalent	Techno-Path Manufacturing , Ltd.
K121122	DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL	Jul 03, 2012	Substantially Equivalent	Biochemical Diagnostic, Inc.
K121143	LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)	May 18, 2012	Substantially Equivalent	Bio-Rad Laboratories
K120504	LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK	Mar 27, 2012	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K103656	THERMO SCIENTIFIC MAS R DOA TOTAL	Mar 24, 2011	Substantially Equivalent	Microgenics Corporation
K093577	LIQUICHEK OPIATE CONTROL	Mar 12, 2010	Substantially Equivalent	Bio-Rad Laboratories
K080085	MAS TOX CONTROL	Apr 30, 2008	Substantially Equivalent	Thermo Fisher Scientific
K080183	CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500	Mar 25, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K072721	LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC	Dec 11, 2007	Substantially Equivalent	Bio-Rad, Diagnostics Grp.
K063398	ESA LEADCARE II LEAD CONTROL	Dec 05, 2006	Substantially Equivalent	Bionostics, Inc.
K062191	DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516	Aug 21, 2006	Substantially Equivalent	Dade Behring, Inc.
K060788	TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414	Jul 10, 2006	Substantially Equivalent	Biosite Incorporated
K060417	MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL	Mar 21, 2006	Substantially Equivalent	Quantimetrix Corp.
K052053	LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK	Aug 09, 2005	Substantially Equivalent	Bio-Rad
K050682	LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)	Apr 29, 2005	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K050037	TRIAGE TOX DRUG SCREEN CONTROLS	Mar 22, 2005	Substantially Equivalent	Biosite Incorporated
K042865	LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)	Nov 24, 2004	Substantially Equivalent	Bio-Rad
K041666	DC-ACETA/SAL CONTROLS	Aug 17, 2004	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K041561	LIQUICHEK WHOLE BLOOD VOLATILES CONTROL	Jul 06, 2004	Substantially Equivalent	Bio-Rad
K040758	MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT	May 28, 2004	Substantially Equivalent	Microgenics Corp.
K033924	LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)	Feb 03, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K033404	LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)	Dec 12, 2003	Substantially Equivalent	Bio-Rad
K033366	LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455	Dec 12, 2003	Substantially Equivalent	Bio-Rad
K032826	MAS PAR TDM	Oct 09, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K022707	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439	Aug 22, 2002	Substantially Equivalent	Bio-Rad
K021415	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469	May 29, 2002	Substantially Equivalent	Bio-Rad
K021414	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467	May 29, 2002	Substantially Equivalent	Bio-Rad
K021411	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463	May 29, 2002	Substantially Equivalent	Bio-Rad
K021384	LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444	May 29, 2002	Substantially Equivalent	Bio-Rad
K013002	TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002	Oct 03, 2001	Substantially Equivalent	Biosite Incorporated
K012999	TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001	Oct 03, 2001	Substantially Equivalent	Biosite Incorporated
K012907	LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL	Sep 28, 2001	Substantially Equivalent	Clinical Controls
K012741	LIQUICHEK TDM CONTROL	Sep 12, 2001	Substantially Equivalent	Bio-Rad
K012319	RANDOX HUMAN ASSSAYED DRUG CONTROL	Aug 24, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K992395	URINE DRUG SCREENING CONTROL	Aug 26, 1999	Substantially Equivalent	Seracare Technology
K990377	ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV	Feb 26, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K983709	SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1	Oct 28, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K983387	ONTRAK TESTCUP AND TESTSTIK CONTROLS	Oct 09, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K983127	OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3	Sep 14, 1998	Substantially Equivalent	Medical Analysis Systems, Inc.
K982649	VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III	Aug 12, 1998	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K982217	AC/AD LINEARITY VERIFIERS	Jul 02, 1998	Substantially Equivalent	Sc Calibrators & Controls, LLC
K982024	OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3	Jun 29, 1998	Substantially Equivalent	Medical Analysis Systems, Inc.
K981590	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON	Jun 10, 1998	Substantially Equivalent	Bio-Rad
K980871	LYPHOCHEK WHOLE BLOOD CONTROL	Apr 06, 1998	Substantially Equivalent	Bio-Rad
K980331	IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S	Mar 16, 1998	Substantially Equivalent	More Diagnostics
K972819	VIGIL TDM CONTROLS	Aug 13, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K971060	PRECINORM TDM CONTROLS	Jul 07, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K972174	LYPHOCHEK REMEDI CONTROL	Jun 24, 1997	Substantially Equivalent	Bio-Rad
K971691	LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3	May 30, 1997	Substantially Equivalent	Bio-Rad
K971534	SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL	May 21, 1997	Substantially Equivalent	Beckman
K971058	DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)	Apr 08, 1997	Substantially Equivalent	Medical Analysis Systems, Inc.
K970666	LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL	Mar 10, 1997	Substantially Equivalent	Bio-Rad
K964771	DE-TOX CONTROL 1 AND DE-TOX CONTROL 19	Feb 04, 1997	Substantially Equivalent	Dyna-Tek Industries
K965157	CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1	Jan 17, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K964422	ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL	Nov 25, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K962165	COBAS-FP TDM CALIBRATION VERIFICATION TEST SET	Jun 26, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K961724	U-DOA CONTROLS	Jun 03, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K960244	DOCUMENT TDM ULTRA ASSAYED CONTROL	Mar 22, 1996	Substantially Equivalent	Casco Standards
K955153	LYPHOCHEK BENZO/TCA CONTROL-SET B	Feb 05, 1996	Substantially Equivalent	Bio-Rad
K955155	DOCUMENT TDM ULTRA UNASSAYED CONTROL	Dec 20, 1995	Substantially Equivalent	Casco Standards
K954799	ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL	Dec 13, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K954291	OPUS TDM CONTROLS	Nov 20, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K954322	TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL	Oct 11, 1995	Substantially Equivalent	Medical Analysis Systems, Inc.
K953845	ABUSCREEN ONLINE DRUG FREE URINE	Sep 20, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K953739	ABUSCREEN ONLINE CONTROLS	Sep 20, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K952412	DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL	Jun 23, 1995	Substantially Equivalent	Dupont Medical Products
K951817	ELI URINE CONTROLS	Jun 19, 1995	Substantially Equivalent	Elsohly Labs, Inc.
K952056	IMMUNOASSAY DRUGS OF ABUSE CONTROLS	Jun 01, 1995	Substantially Equivalent	Medi-Tech, Inc.
K951135	MULTI-DRUG CONTROL SET	Apr 13, 1995	Substantially Equivalent	Microgenics Corp.
K950138	DRUGS OF ABUSE CONTROLS	Feb 22, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K943999	ABUSCREEN ONTRAK POSITIVE CONTROL	Jan 25, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K945194	ABUSCREEN ONLINE CONTROLS	Dec 09, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K943422	TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL	Nov 02, 1994	Substantially Equivalent	Utak Lab, Inc.
K942551	THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED	Oct 06, 1994	Substantially Equivalent	Medi-Tech, Inc.
K942257	DOA-PLUS, DRUGS OF ABUSE CONTROLS	Sep 14, 1994	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K942041	NIDA-5/RT, DRUG OF ABUSE CONTROLS	Sep 14, 1994	Substantially Equivalent	Meditech
K942552	THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED	Sep 09, 1994	Substantially Equivalent	Medi-Tech, Inc.
K942114	ROCHE TDM CALIBRATION VERIFICATION TEST SET	Sep 02, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K940433	DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4	Jul 20, 1994	Substantially Equivalent	Medical Analysis Systems, Inc.
K936166	CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS	Jul 13, 1994	Substantially Equivalent	Medical Analysis Systems, Inc.
K934498	DOA LIQUID DRUGS OF ABUSE CONTROLS	Jul 06, 1994	Substantially Equivalent	Medical Analysis Systems, Inc.
K934650	CEDIA DAU CONTROLS	Apr 26, 1994	Substantially Equivalent	Medical Analysis Systems, Inc.
K935285	DRUGS OF ABUSE CONTROLS	Mar 22, 1994	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K935230	EMIT IIC NEGATIVE CONTROL, CONTROL I AND II	Jan 03, 1994	Substantially Equivalent	Syva Co.
K934062	BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS	Dec 29, 1993	Substantially Equivalent	Biotrack, Inc.
K932549	ABUSCREEN ONLINE LOW-CUTOFF CONTROLS	Aug 26, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K931125	ABUSCREEN ONLINE CONTROL	Aug 03, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K932643	LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL	Jul 08, 1993	Substantially Equivalent	Bio-Rad
K931105	PROCHECK(TM) BLIND PERFORMANCE SPECIMENS	Apr 21, 1993	Substantially Equivalent	Dynagen, Inc.
K930269	COBAS-FP TDM CONTROLS	Feb 25, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K925586	DETECTABUSE(TM)	Dec 28, 1992	Substantially Equivalent	Biochemical Diagnostic, Inc.
K920477	DRUG OF ABUSE URINE CONTROL	Mar 18, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K914170	LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)	Nov 22, 1991	Substantially Equivalent	Bio-Rad
K914806	ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL	Nov 19, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K913309	TDM I LINEARITY TEST SET	Sep 13, 1991	Substantially Equivalent	Casco Standards
K913650	DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL	Sep 06, 1991	Substantially Equivalent	Duo Research, Inc.
K911724	ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION	May 22, 1991	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K911168	ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K911167	ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K910930	ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K905457	CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL	Apr 16, 1991	Substantially Equivalent	Consolidated Technologies, Inc.
K910333	CHALLENGE (TM) LIQ THERA DRUG CONTROLS	Apr 12, 1991	Substantially Equivalent	Medical Analysis Systems, Inc.
K904905	DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS	Dec 11, 1990	Substantially Equivalent	Medical Analysis Systems, Inc.
K903909	BLIND CONTROLS FOR DRUGS OF ABUSE TESTING	Oct 26, 1990	Substantially Equivalent	Rapid Diagnostic Laboratories, Inc.
K903189	KODATROL LIQUID CONTROL LEVELS I & II	Aug 22, 1990	Substantially Equivalent	Eastman Kodak Company
K901270	LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN	May 02, 1990	Substantially Equivalent	Bio-Rad
K901271	LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM	Apr 11, 1990	Substantially Equivalent	Bio-Rad
K900626	ALPHA URINE SAMPLE	Mar 06, 1990	Substantially Equivalent	Toxi-Lab, Inc.
K892380	DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III	Feb 08, 1990	Substantially Equivalent	Baxter Healthcare Corp
K895816	BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.	Dec 07, 1989	Substantially Equivalent	Bio-Rad
K893682	KIT- CIBA CORNING L-TDM I, II, III	Sep 28, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K893835	DAU I, DAU II, DAU III AND DAU IV CONTROL URINE	Jul 25, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K890957	HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:	Mar 09, 1989	Substantially Equivalent	Hycor Biomedical, Inc.
K884178	DRUG CONTROL SET	Feb 17, 1989	Substantially Equivalent	Gelman Sciences, Inc.
K890406	DETECTABUSE DRUG CONTROLS	Feb 10, 1989	Substantially Equivalent	Eastern Laboratories, Ltd.
K890030	NEW LOW LEVEL DRUG MIXTURE CONTROL	Jan 23, 1989	Substantially Equivalent	Rapid Diagnostic Laboratories, Inc.
K883210	EMIT (R) HVA NEGATIVE URINE	Sep 19, 1988	Substantially Equivalent	Syva Co.
K883190	DADE TDM CONTROL	Sep 09, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881944	EMIT HVA CONTROL KIT	Jul 08, 1988	Substantially Equivalent	Syva Co.
K881991	LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE	Jun 20, 1988	Substantially Equivalent	Bio-Rad
K881990	LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW	Jun 20, 1988	Substantially Equivalent	Bio-Rad
K881989	LYPHOCHEK URINE TOXICOLOGY CONTROL	Jun 20, 1988	Substantially Equivalent	Bio-Rad
K880145	LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL	Jun 20, 1988	Substantially Equivalent	Bio-Rad
K880152	PAR(TM) BRAND DRUG OF ABUSE CONTROLS	May 31, 1988	Substantially Equivalent	Medical Analysis Systems, Inc.
K880512	DRUG MIXTURE CONTROL IN URINE	Apr 05, 1988	Substantially Equivalent	Eastern Laboratories, Ltd.
K880445	LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW	Apr 05, 1988	Substantially Equivalent	Bio-Rad
K880444	LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE	Feb 25, 1988	Substantially Equivalent	Bio-Rad
K874757	STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III	Feb 02, 1988	Substantially Equivalent	Baxter Healthcare Corp
K873183	TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K873539	ACA URINE DRUGS OF ABUSE CONTROL	Oct 07, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K873037	CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL	Oct 02, 1987	Substantially Equivalent	Diagnostic Products Corp.
K873467	QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL	Sep 29, 1987	Substantially Equivalent	Quantimetrix Medical Industries
K871694	HYPERFORMANCE CONTROLS (HP-CONTROLS)	Jul 07, 1987	Substantially Equivalent	Rapid Diagnostic Laboratories, Inc.
K871788	LIQUID TDM CONTROLS	Jun 17, 1987	Substantially Equivalent	Biological Industries
K870586	TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG	Apr 01, 1987	Substantially Equivalent	Medical Analysis Systems, Inc.
K863388	QUANTIMETRIX DRUG FREE SERUM CONTROL	Sep 29, 1986	Substantially Equivalent	Quantimetrix Corp.
K862817	V-TREND QC TDM CONTROL SERUM 1,2,3.	Aug 19, 1986	Substantially Equivalent	Texas Immunology, Inc.
K861970	LYPHOCHEK URINE TOXICOLOGY CONTROL	Aug 19, 1986	Substantially Equivalent	Bio-Rad
K860919	THERACHEM, TDC THERAPEUTIC DRUG CONTROLS	Apr 11, 1986	Substantially Equivalent	Fisher Scientific Co., LLC
K860097	THERAPEUTIC DRUG (TDM) CALIBRATOR	Feb 11, 1986	Substantially Equivalent	Instrumentation Laboratory CO
K853933	QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL	Oct 04, 1985	Substantially Equivalent	Quantimetrix Corp.
K852414	LYPHOCHEK DRUG FREE SERUM(HUMAN)	Jul 24, 1985	Substantially Equivalent	Bio-Rad
K844946	EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL	Jan 18, 1985	Substantially Equivalent	Syva Co.
K844945	EMIT IMIPRAMINE/DESIPRAMINE CONTROL	Jan 18, 1985	Substantially Equivalent	Syva Co.
K843913	COBAS FP TDM CONTROLS	Oct 30, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K843818	HUMAN SERUM ANTICONVULSANT DRUG CONTROL	Oct 30, 1984	Substantially Equivalent	Quantimetrix Corp.
K843679	HUMAN SERUM CARDIOACTIVE DRUG CONTROL	Oct 05, 1984	Substantially Equivalent	Quantimetrix Corp.
K843508	EMIT 700 CONTROL SET B	Sep 28, 1984	Substantially Equivalent	Syva Co.
K843161	EMIT 700 CONTROL SET A	Aug 29, 1984	Substantially Equivalent	Syva Co.
K841439	COMA TOXICOLOGY CONTROL	May 16, 1984	Substantially Equivalent	American Dade
K840921	THERACHEM TDC THERAPEUTIC DRUG CONTROL	Apr 05, 1984	Substantially Equivalent	Fisher Diagnostics
K834259	LIQUI-URA TOXIC URINE CONTROL	Jan 30, 1984	Substantially Equivalent	Biodiagnostic Intl
K833794	LYPHOCHEK THERAPEUTIC DRUG CONTROL	Jan 24, 1984	Substantially Equivalent	Bio-Rad
K831736	TRICYCLIC ANTIDEPRESSANTS	Jul 28, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831741	FLURAZEPAM TOXICOLOGY CONTROL	Jul 26, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831734	AMOXAPINE 8-HYDRO-XYAMOXAPINE	Jul 26, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831737	TRICYCLIC ANTIDEPRESSNATS VI	Jul 19, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831740	DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE	Jul 06, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831500	TRI-LEVEL TDM CONTROL & I II III	Jun 30, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K831278	LIQUI-SERA ANTICONVULSANTS CONTROLS	May 27, 1983	Substantially Equivalent	Biodiagnostic Intl
K830518	EMIT-ST PHOTOMETER & DILUTER VERIFICA	Apr 05, 1983	Substantially Equivalent	Syva Co.
K830494	CONTOX DRUG SCREEN CONTROL	Mar 11, 1983	Substantially Equivalent	Kaulson Laboratories, Inc.
K830492	CONTOX DURG CONTROL	Mar 11, 1983	Substantially Equivalent	Kaulson Laboratories, Inc.
K830234	CONTOX HEAVYMETALS CONTROL	Feb 18, 1983	Substantially Equivalent	Kaulson Laboratories, Inc.
K823746	ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG	Jan 12, 1983	Substantially Equivalent	Syva Co.
K822777	THERAPEUTIC DRUG CONTROL	Oct 08, 1982	Substantially Equivalent	Icl Scientific
K821975	ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX	Aug 27, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K821973	Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.	Jul 20, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K821950	Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED	Jul 20, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K820296	STRATUS TDM CONTROL, LEVELS I,II,III	May 14, 1982	Substantially Equivalent	American Dade
K820468	PROFILE GENERAL SET ASSAYED SERUM CONTR	Mar 25, 1982	Substantially Equivalent	General Diagnostics
K820462	EMIT-ST URINE CONTROLS SET A #3A349	Mar 11, 1982	Substantially Equivalent	Syva Co.
K820191	CONTROL SET	Feb 12, 1982	Substantially Equivalent	Syva Co.
K813349	BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL	Dec 22, 1981	Substantially Equivalent	Stanbio Laboratory
K812950	QAC CONTROL	Dec 17, 1981	Substantially Equivalent	The Quality Assurance Service Corp.
K811756	THERAPEUTIC DRUG CONTROL	Jul 15, 1981	Substantially Equivalent	Icl Scientific
K811811	TDM ANTI-CONVULSANT CONTROL LEVELS I-II	Jul 10, 1981	Substantially Equivalent	Environmental Chemical Specialties
K811809	ANTI-ARRHYTHMIC CONTROL LEVELS I & II	Jul 10, 1981	Substantially Equivalent	Environmental Chemical Specialties
K811618	EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL	Jun 25, 1981	Substantially Equivalent	Syva Co.
K810504	THERACHEM ANTI CONVULSANTA THEOPHYLLINE	Mar 11, 1981	Substantially Equivalent	Fisher Scientific Co., LLC
K810468	EMIT-ST SERUM CONTROLS	Mar 06, 1981	Substantially Equivalent	Syva Co.
K810235	ACETAMINOPHEN/SALICYLATE CONTROL	Feb 10, 1981	Substantially Equivalent	Clin Tech Diagnostics Corp.
K810078	Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S	Feb 02, 1981	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K810077	OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.	Jan 28, 1981	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K803097	DIGOXIN & PHENYTOIN CONTROL SERA	Dec 22, 1980	Substantially Equivalent	Amersham Corp.
K803039	PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.	Dec 22, 1980	Substantially Equivalent	General Diagnostics
K803036	PROFILE CARDIAC SET ASSAYED SERUM CONTR.	Dec 22, 1980	Substantially Equivalent	General Diagnostics
K802854	BECKMAN ICS DRUG CONTROL SERA	Dec 11, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K802672	CARDIOACTIVE DRUGS CONTROL	Nov 24, 1980	Substantially Equivalent	Fisher Scientific Co., LLC
K802278	IN VITRO DIAGNOSTIC STANDARDS	Nov 24, 1980	Substantially Equivalent	Supelco, Inc.
K800888	TRICYCLIC ANTIDEPRESSANTS I TX CONTROL	May 02, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800889	TRICYCLIC ANTIDEPRESSANT II TX CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800887	HYPNOTICS PLUS SALICYLATE TX CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800886	HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800885	BARBITURATES TOXICOLOGY CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800884	CARDIACS II TOXICOLOGY CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800883	CARDIACS I TOXICOLOGY CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K800882	ANTICONVULSANTS TOXICOLOGY CONTROL	Apr 29, 1980	Substantially Equivalent	Utak Laboratories, Inc.
K782128	THERA CHEM	Mar 02, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K780960	SERUM, CONTROL, DRUGS, ANTIARRYTHMIC	Dec 07, 1978	Substantially Equivalent	Vitek Systems, Inc.