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 |