FDA 510(k) Applications for Medical Device Product Code "DIF"
(Drug Mixture Control Materials)

FDA 510(k) Number Applicant Device Name Decision Date
K873183 ABBOTT LABORATORIES TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS 11/23/1987
K841439 AMERICAN DADE COMA TOXICOLOGY CONTROL 05/16/1984
K820296 AMERICAN DADE STRATUS TDM CONTROL, LEVELS I,II,III 05/14/1982
K803097 AMERSHAM CORP. DIGOXIN & PHENYTOIN CONTROL SERA 12/22/1980
K911167 ANALYTICAL CONTROL SYSTEMS, INC. ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II 05/01/1991
K911168 ANALYTICAL CONTROL SYSTEMS, INC. ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III 05/01/1991
K910930 ANALYTICAL CONTROL SYSTEMS, INC. ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 05/01/1991
K883190 BAXTER HEALTHCARE CORP. DADE TDM CONTROL 09/09/1988
K892380 BAXTER HEALTHCARE CORP. DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III 02/08/1990
K874757 BAXTER HEALTHCARE CORP. STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III 02/02/1988
K971534 BECKMAN SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL 05/21/1997
K983709 BECKMAN COULTER, INC. SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 10/28/1998
K802854 BECKMAN INSTRUMENTS, INC. BECKMAN ICS DRUG CONTROL SERA 12/11/1980
K972819 BECKMAN INSTRUMENTS, INC. VIGIL TDM CONTROLS 08/13/1997
K954291 BEHRING DIAGNOSTICS, INC. OPUS TDM CONTROLS 11/20/1995
K831278 BIO DIAGNOSTIC INTL. LIQUI-SERA ANTICONVULSANTS CONTROLS 05/27/1983
K834259 BIO DIAGNOSTIC INTL. LIQUI-URA TOXIC URINE CONTROL 01/30/1984
K895816 BIO-RAD BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. 12/07/1989
K970666 BIO-RAD LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL 03/10/1997
K033366 BIO-RAD LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 12/12/2003
K052053 BIO-RAD LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK 08/09/2005
K012741 BIO-RAD LIQUICHEK TDM CONTROL 09/12/2001
K914170 BIO-RAD LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) 11/22/1991
K033404 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) 12/12/2003
K971691 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 05/30/1997
K981590 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON 06/10/1998
K021415 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 05/29/2002
K021414 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 05/29/2002
K021411 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 05/29/2002
K022707 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 08/22/2002
K021384 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 05/29/2002
K042865 BIO-RAD LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) 11/24/2004
K041561 BIO-RAD LIQUICHEK WHOLE BLOOD VOLATILES CONTROL 07/06/2004
K955153 BIO-RAD LYPHOCHEK BENZO/TCA CONTROL-SET B 02/05/1996
K852414 BIO-RAD LYPHOCHEK DRUG FREE SERUM(HUMAN) 07/24/1985
K972174 BIO-RAD LYPHOCHEK REMEDI CONTROL 06/24/1997
K833794 BIO-RAD LYPHOCHEK THERAPEUTIC DRUG CONTROL 01/24/1984
K880145 BIO-RAD LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL 06/20/1988
K861970 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL 08/19/1986
K881989 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL 06/20/1988
K901271 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM 04/11/1990
K880445 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW 04/05/1988
K881990 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW 06/20/1988
K880444 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE 02/25/1988
K881991 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE 06/20/1988
K901270 BIO-RAD LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN 05/02/1990
K980871 BIO-RAD LYPHOCHEK WHOLE BLOOD CONTROL 04/06/1998
K932643 BIO-RAD LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL 07/08/1993
K093577 Bio-Rad Laboratories LIQUICHEK OPIATE CONTROL 03/12/2010
K121143 Bio-Rad Laboratories LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) 05/18/2012
K050682 BIO-RAD LABORATORIES, INC. LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) 04/29/2005
K033924 BIO-RAD LABORATORIES, INC. LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) 02/03/2004
K120504 BIO-RAD LABORATORIES, INC. LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK 03/27/2012
K072721 BIO-RAD, DIAGNOSTICS GRP. LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC 12/11/2007
K121122 BIOCHEMICAL DIAGNOSTIC, INC. DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL 07/03/2012
K925586 BIOCHEMICAL DIAGNOSTIC, INC. DETECTABUSE(TM) 12/28/1992
K153474 BIOCHEMICAL DIAGNOSTICS, INC 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 02/23/2016
K132688 BIOCHEMICAL DIAGNOSTICS, INC. SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ 12/16/2013
K871788 BIOLOGICAL INDUSTRIES LIQUID TDM CONTROLS 06/17/1987
K063398 BIONOSTICS, INC. ESA LEADCARE II LEAD CONTROL 12/05/2006
K013002 BIOSITE INCORPORATED TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 10/03/2001
K060788 BIOSITE INCORPORATED TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 07/10/2006
K050037 BIOSITE INCORPORATED TRIAGE TOX DRUG SCREEN CONTROLS 03/22/2005
K012999 BIOSITE INCORPORATED TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 10/03/2001
K934062 BIOTRACK, INC. BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS 12/29/1993
K965157 BOEHRINGER MANNHEIM CORP. CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 01/17/1997
K971060 BOEHRINGER MANNHEIM CORP. PRECINORM TDM CONTROLS 07/07/1997
K960244 CASCO STANDARDS DOCUMENT TDM ULTRA ASSAYED CONTROL 03/22/1996
K955155 CASCO STANDARDS DOCUMENT TDM ULTRA UNASSAYED CONTROL 12/20/1995
K913309 CASCO STANDARDS TDM I LINEARITY TEST SET 09/13/1991
K893835 CIBA CORNING DIAGNOSTICS CORP. DAU I, DAU II, DAU III AND DAU IV CONTROL URINE 07/25/1989
K893682 CIBA CORNING DIAGNOSTICS CORP. KIT- CIBA CORNING L-TDM I, II, III 09/28/1989
K012907 CLINICAL CONTROLS LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL 09/28/2001
K810235 CLINTECH DIAGNOSTICS CORP. ACETAMINOPHEN/SALICYLATE CONTROL 02/10/1981
K905457 CONSOLIDATED TECHNOLOGIES, INC. CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL 04/16/1991
K062191 DADE BEHRING, INC. DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 08/21/2006
K041666 DIAGNOSTIC CHEMICALS LTD. DC-ACETA/SAL CONTROLS 08/17/2004
K873037 DIAGNOSTIC PRODUCTS CORP. CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL 10/02/1987
K920477 DIAGNOSTIC REAGENTS, INC. DRUG OF ABUSE URINE CONTROL 03/18/1992
K913650 DUO RESEARCH, INC. DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL 09/06/1991
K952412 DUPONT MEDICAL PRODUCTS DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL 06/23/1995
K964771 DYNA-TEK INDUSTRIES DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 02/04/1997
K931105 DYNAGEN, INC. PROCHECK(TM) BLIND PERFORMANCE SPECIMENS 04/21/1993
K873539 E.I. DUPONT DE NEMOURS & CO., INC. ACA URINE DRUGS OF ABUSE CONTROL 10/07/1987
K911724 E.I. DUPONT DE NEMOURS & CO., INC. ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION 05/22/1991
K950138 E.I. DUPONT DE NEMOURS & CO., INC. DRUGS OF ABUSE CONTROLS 02/22/1995
K890406 EASTERN LABORATORIES, LTD. DETECTABUSE DRUG CONTROLS 02/10/1989
K880512 EASTERN LABORATORIES, LTD. DRUG MIXTURE CONTROL IN URINE 04/05/1988
K903189 EASTMAN KODAK COMPANY KODATROL LIQUID CONTROL LEVELS I & II 08/22/1990
K951817 ELSOHLY LABS, INC. ELI URINE CONTROLS 06/19/1995
K811809 ENVIRONMENTAL CHEMICAL SPECIALTIES ANTI-ARRHYTHMIC CONTROL LEVELS I & II 07/10/1981
K811811 ENVIRONMENTAL CHEMICAL SPECIALTIES TDM ANTI-CONVULSANT CONTROL LEVELS I-II 07/10/1981
K840921 FISHER DIAGNOSTICS THERACHEM TDC THERAPEUTIC DRUG CONTROL 04/05/1984
K802672 FISHER SCIENTIFIC CO., LLC. CARDIOACTIVE DRUGS CONTROL 11/24/1980
K782128 FISHER SCIENTIFIC CO., LLC. THERA CHEM 03/02/1979
K810504 FISHER SCIENTIFIC CO., LLC. THERACHEM ANTI CONVULSANTA THEOPHYLLINE 03/11/1981
K860919 FISHER SCIENTIFIC CO., LLC. THERACHEM, TDC THERAPEUTIC DRUG CONTROLS 04/11/1986
K884178 GELMAN SCIENCES, INC. DRUG CONTROL SET 02/17/1989
K803039 GENERAL DIAGNOSTICS PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. 12/22/1980
K803036 GENERAL DIAGNOSTICS PROFILE CARDIAC SET ASSAYED SERUM CONTR. 12/22/1980
K820468 GENERAL DIAGNOSTICS PROFILE GENERAL SET ASSAYED SERUM CONTR 03/25/1982
K890957 HYCOR BIOMEDICAL, INC. HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL: 03/09/1989
K810077 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. 01/28/1981
K810078 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S 02/02/1981
K811756 ICL SCIENTIFIC THERAPEUTIC DRUG CONTROL 07/15/1981
K822777 ICL SCIENTIFIC THERAPEUTIC DRUG CONTROL 10/08/1982
K860097 INSTRUMENTATION LABORATORY CO. THERAPEUTIC DRUG (TDM) CALIBRATOR 02/11/1986
K830494 KAULSON LABORATORIES, INC. CONTOX DRUG SCREEN CONTROL 03/11/1983
K830492 KAULSON LABORATORIES, INC. CONTOX DURG CONTROL 03/11/1983
K830234 KAULSON LABORATORIES, INC. CONTOX HEAVYMETALS CONTROL 02/18/1983
K952056 MEDI-TECH, INC. IMMUNOASSAY DRUGS OF ABUSE CONTROLS 06/01/1995
K942551 MEDI-TECH, INC. THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED 10/06/1994
K942552 MEDI-TECH, INC. THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED 09/09/1994
K934650 MEDICAL ANALYSIS SYSTEMS, INC. CEDIA DAU CONTROLS 04/26/1994
K910333 MEDICAL ANALYSIS SYSTEMS, INC. CHALLENGE (TM) LIQ THERA DRUG CONTROLS 04/12/1991
K936166 MEDICAL ANALYSIS SYSTEMS, INC. CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS 07/13/1994
K934498 MEDICAL ANALYSIS SYSTEMS, INC. DOA LIQUID DRUGS OF ABUSE CONTROLS 07/06/1994
K940433 MEDICAL ANALYSIS SYSTEMS, INC. DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 07/20/1994
K904905 MEDICAL ANALYSIS SYSTEMS, INC. DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS 12/11/1990
K971058 MEDICAL ANALYSIS SYSTEMS, INC. DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) 04/08/1997
K032826 MEDICAL ANALYSIS SYSTEMS, INC. MAS PAR TDM 10/09/2003
K982024 MEDICAL ANALYSIS SYSTEMS, INC. OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 06/29/1998
K983127 MEDICAL ANALYSIS SYSTEMS, INC. OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 09/14/1998
K880152 MEDICAL ANALYSIS SYSTEMS, INC. PAR(TM) BRAND DRUG OF ABUSE CONTROLS 05/31/1988
K870586 MEDICAL ANALYSIS SYSTEMS, INC. TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG 04/01/1987
K954322 MEDICAL ANALYSIS SYSTEMS, INC. TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL 10/11/1995
K942257 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. DOA-PLUS, DRUGS OF ABUSE CONTROLS 09/14/1994
K935285 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. DRUGS OF ABUSE CONTROLS 03/22/1994
K961724 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. U-DOA CONTROLS 06/03/1996
K942041 MEDITECH NIDA-5/RT, DRUG OF ABUSE CONTROLS 09/14/1994
K040758 MICROGENICS CORP. MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT 05/28/2004
K951135 MICROGENICS CORP. MULTI-DRUG CONTROL SET 04/13/1995
K103656 Microgenics Corporation THERMO SCIENTIFIC MAS R DOA TOTAL 03/24/2011
K980331 MORE DIAGNOSTICS IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S 03/16/1998
K821975 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX 08/27/1982
K831500 ORTHO DIAGNOSTIC SYSTEMS, INC. TRI-LEVEL TDM CONTROL & I II III 06/30/1983
K982649 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III 08/12/1998
K843818 QUANTIMETRIX CORP. HUMAN SERUM ANTICONVULSANT DRUG CONTROL 10/30/1984
K843679 QUANTIMETRIX CORP. HUMAN SERUM CARDIOACTIVE DRUG CONTROL 10/05/1984
K060417 QUANTIMETRIX CORP. MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL 03/21/2006
K863388 QUANTIMETRIX CORP. QUANTIMETRIX DRUG FREE SERUM CONTROL 09/29/1986
K853933 QUANTIMETRIX CORP. QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL 10/04/1985
K873467 QUANTIMETRIX MEDICAL INDUSTRIES QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL 09/29/1987
K012319 RANDOX LABORATORIES, LTD. RANDOX HUMAN ASSSAYED DRUG CONTROL 08/24/2001
K903909 RAPID DIAGNOSTIC LABORATORIES, INC. BLIND CONTROLS FOR DRUGS OF ABUSE TESTING 10/26/1990
K871694 RAPID DIAGNOSTIC LABORATORIES, INC. HYPERFORMANCE CONTROLS (HP-CONTROLS) 07/07/1987
K890030 RAPID DIAGNOSTIC LABORATORIES, INC. NEW LOW LEVEL DRUG MIXTURE CONTROL 01/23/1989
K931125 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE CONTROL 08/03/1993
K945194 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE CONTROLS 12/09/1994
K953739 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE CONTROLS 09/20/1995
K953845 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE DRUG FREE URINE 09/20/1995
K932549 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE LOW-CUTOFF CONTROLS 08/26/1993
K943999 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONTRAK POSITIVE CONTROL 01/25/1995
K914806 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL 11/19/1991
K843913 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS FP TDM CONTROLS 10/30/1984
K962165 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP TDM CALIBRATION VERIFICATION TEST SET 06/26/1996
K930269 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP TDM CONTROLS 02/25/1993
K954799 ROCHE DIAGNOSTIC SYSTEMS, INC. ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL 12/13/1995
K983387 ROCHE DIAGNOSTIC SYSTEMS, INC. ONTRAK TESTCUP AND TESTSTIK CONTROLS 10/09/1998
K964422 ROCHE DIAGNOSTIC SYSTEMS, INC. ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL 11/25/1996
K942114 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE TDM CALIBRATION VERIFICATION TEST SET 09/02/1994
K080183 ROCHE DIAGNOSTICS CORP. CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 03/25/2008
K990377 ROCHE DIAGNOSTICS CORP. ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV 02/26/1999
K982217 SC CALIBRATORS & CONTROLS LLC. AC/AD LINEARITY VERIFIERS 07/02/1998
K992395 SERACARE TECHNOLOGY URINE DRUG SCREENING CONTROL 08/26/1999
K813349 STANBIO LABORATORY BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL 12/22/1981
K802278 SUPELCO, INC. IN VITRO DIAGNOSTIC STANDARDS 11/24/1980
K823746 SYVA CO. ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG 01/12/1983
K820191 SYVA CO. CONTROL SET 02/12/1982
K883210 SYVA CO. EMIT (R) HVA NEGATIVE URINE 09/19/1988
K843161 SYVA CO. EMIT 700 CONTROL SET A 08/29/1984
K843508 SYVA CO. EMIT 700 CONTROL SET B 09/28/1984
K844946 SYVA CO. EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL 01/18/1985
K881944 SYVA CO. EMIT HVA CONTROL KIT 07/08/1988
K935230 SYVA CO. EMIT IIC NEGATIVE CONTROL, CONTROL I AND II 01/03/1994
K844945 SYVA CO. EMIT IMIPRAMINE/DESIPRAMINE CONTROL 01/18/1985
K811618 SYVA CO. EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL 06/25/1981
K830518 SYVA CO. EMIT-ST PHOTOMETER & DILUTER VERIFICA 04/05/1983
K810468 SYVA CO. EMIT-ST SERUM CONTROLS 03/06/1981
K820462 SYVA CO. EMIT-ST URINE CONTROLS SET A #3A349 03/11/1982
K132174 TECHNO-PATH MANUFACTURING LTD. MULTICHEM WBT 09/20/2013
K862817 TEXAS IMMUNOLOGY, INC. V-TREND QC TDM CONTROL SERUM 1,2,3. 08/19/1986
K812950 THE QUALITY ASSURANCE SERVICE CORP. QAC CONTROL 12/17/1981
K080085 Thermo Fisher Scientific MAS TOX CONTROL 04/30/2008
K900626 TOXI-LAB, INC. ALPHA URINE SAMPLE 03/06/1990
K821950 TRAVENOL LABORATORIES, S.A. Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED 07/20/1982
K821973 TRAVENOL LABORATORIES, S.A. Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. 07/20/1982
K943422 UTAK LAB, INC. TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL 11/02/1994
K831734 UTAK LABORATORIES, INC. AMOXAPINE 8-HYDRO-XYAMOXAPINE 07/26/1983
K800882 UTAK LABORATORIES, INC. ANTICONVULSANTS TOXICOLOGY CONTROL 04/29/1980
K800885 UTAK LABORATORIES, INC. BARBITURATES TOXICOLOGY CONTROL 04/29/1980
K800883 UTAK LABORATORIES, INC. CARDIACS I TOXICOLOGY CONTROL 04/29/1980
K800884 UTAK LABORATORIES, INC. CARDIACS II TOXICOLOGY CONTROL 04/29/1980
K831740 UTAK LABORATORIES, INC. DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE 07/06/1983
K831741 UTAK LABORATORIES, INC. FLURAZEPAM TOXICOLOGY CONTROL 07/26/1983
K800886 UTAK LABORATORIES, INC. HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL 04/29/1980
K800887 UTAK LABORATORIES, INC. HYPNOTICS PLUS SALICYLATE TX CONTROL 04/29/1980
K800889 UTAK LABORATORIES, INC. TRICYCLIC ANTIDEPRESSANT II TX CONTROL 04/29/1980
K831736 UTAK LABORATORIES, INC. TRICYCLIC ANTIDEPRESSANTS 07/28/1983
K800888 UTAK LABORATORIES, INC. TRICYCLIC ANTIDEPRESSANTS I TX CONTROL 05/02/1980
K831737 UTAK LABORATORIES, INC. TRICYCLIC ANTIDEPRESSNATS VI 07/19/1983
K780960 VITEK SYSTEMS, INC. SERUM, CONTROL, DRUGS, ANTIARRYTHMIC 12/07/1978


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