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 |
| K953739 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CONTROLS | 09/20/1995 |
| K945194 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CONTROLS | 12/09/1994 |
| 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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