FDA 510(k) Applications for Medical Device Product Code "DKB"
(Calibrators, Drug Mixture)

FDA 510(k) Number Applicant Device Name Decision Date
K013959 BAYER DIAGNOSTICS CORP. BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS 01/29/2002
K983209 BECKMAN COULTER, INC. SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I 11/04/1998
K983747 BECKMAN COULTER, INC. SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II 12/30/1998
K993954 BECKMAN COULTER, INC. SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS 01/11/2000
K981403 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT 05/08/1998
K971287 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS 05/08/1997
K971600 BEHRING DIAGNOSTICS, INC. EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) 06/25/1997
K834398 BIO DIAGNOSTIC INTL. LIQUI-SERA TDM CALIBRATORS 02/03/1984
K963191 BOEHRINGER MANNHEIM CORP. CEDIA ANTIBIOTIC TDM MULTI-CALS 09/10/1996
K954608 BOEHRINGER MANNHEIM CORP. CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH 12/26/1995
K980853 BOEHRINGER MANNHEIM CORP. CEDIA DAU MULTI-DRUG CALIBRATORS 04/21/1998
K974699 CONSOLIDATED TECHNOLOGIES, INC. REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE 01/22/1998
K990255 DADE BEHRING, INC. DIMENSION DRUG CALIBRATOR II, MODEL DC49B 02/16/1999
K032574 DADE BEHRING, INC. DIMENSION DRUG CALIBRATOR II, MODEL DC49C 10/06/2003
K062121 DADE BEHRING, INC. DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) 08/25/2006
K062162 DADE BEHRING, INC. DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) 09/14/2006
K982871 DADE BEHRING, INC. DRUG CALIBRATOR II 10/13/1998
K962817 DADE INTL., INC. DRUG CALIBRATOR II 09/16/1996
K961273 DIAGNOSTIC REAGENTS, INC. AED CALIBRATORS 05/15/1996
K983159 DIAGNOSTIC REAGENTS, INC. DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS 11/05/1998
K961372 DIAGNOSTIC REAGENTS, INC. SERUM TOX CALIBRATOR 05/01/1996
K920208 DIAGNOSTIC REAGENTS, INC. URINE A CALIBRATOR 03/04/1992
K940935 DIAGNOSTIC REAGENTS, INC. URINE CALIBRATOR 07/06/1994
K935101 DIAGNOSTIC REAGENTS, INC. URINE CALIBRATORS AND CONTROLS MODIFICATION 01/27/1994
K862403 DIAGNOSTIC SYSTEMS EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 07/11/1986
K842386 E.I. DUPONT DE NEMOURS & CO., INC. ACA BARBITURATES SCREEN/BENZODIAZEPIN 08/15/1984
K872392 E.I. DUPONT DE NEMOURS & CO., INC. ACA URINE DRUGS OF ABUSE CALIBRATOR 09/14/1987
K950139 E.I. DUPONT DE NEMOURS & CO., INC. DRUGS OF ABUSE CALIBRATOR 02/22/1995
K910881 GDS DIAGNOSTICS CONTROL AND LINEARITY 09/13/1991
K884177 GELMAN SCIENCES, INC. DRUG STANDARD SET 02/17/1989
K892332 HYCOR BIOMEDICAL, INC. DRUGS OF ABUSE URINE CALIBRATORS 05/11/1989
K894934 HYCOR BIOMEDICAL, INC. HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS 10/17/1989
K893815 HYCOR BIOMEDICAL, INC. HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS 07/25/1989
K833761 ICL SCIENTIFIC THERAPEUTIC DRUG CONTROL 01/13/1984
K913740 INSTRUMENTATION LABORATORY CO. IL TEST(TM) DAT CAL/CONTROL SET B 10/21/1991
K913741 INSTRUMENTATION LABORATORY CO. IL TEST(TM) DAT CAL/CONTROL SET C 10/21/1991
K913739 INSTRUMENTATION LABORATORY CO. IL TEST(TM) DAT CALIBRATOR A( -) 09/10/1991
K133710 Lin-Zhi International, Inc. LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS 02/21/2014
K051088 Lin-Zhi International, Inc. MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS 06/24/2005
K033879 MAINE STANDARDS CO. VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 02/27/2004
K945289 MEDI-TECH, INC. DOA - IMMUNOASSAY CUT-OFF CALIBRATOR 12/13/1994
K935794 MICROGENICS CORP. CEDIA DAU 4-DRUG CUTOFF CALIBRATOR 01/25/1994
K935792 MICROGENICS CORP. CEDIA DAU 5-DRUG CALIBRATORS 01/25/1994
K935793 MICROGENICS CORP. CEDIA DAU NEGATIVE CALIBRATOR 03/14/1994
K936028 MICROGENICS CORP. CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB 03/14/1994
K101752 MICROGENICS CORP. THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS 04/08/2011
K120936 Microgenics Corporation ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS 12/13/2012
K021393 QUANTIMETRIX CORP. PRECISET DAT PLUS 06/13/2002
K092266 RANDOX LABORATORIES, LTD. RANDOX METHAMPHETAMINE ASSAY 05/09/2011
K012318 RANDOX LABORATORIES, LTD. RANDOX THERAPEUTIC DRUG CALIBRATOR 09/12/2001
K875216 RAPID DIAGNOSTIC LABORATORIES, INC. HIGH PERFORMANCE CALIBRATORS 06/22/1988
K932754 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN CALIBRATION STANDARD 07/22/1993
K910085 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS 03/11/1991
K935550 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK 01/03/1994
K910087 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE OPIATES CALIBRATORS 02/04/1991
K931124 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE(R) CALIBRATORS 08/03/1993
K905828 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONLINE CALIBRATORS 02/04/1991
K913335 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONLINE(TM) CALIBRATORS 08/26/1991
K923340 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN ONLINNE CALIBRATORS 08/04/1992
K932753 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS 07/22/1993
K942048 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE AMMONIA (VARIOUS) 10/04/1994
K090939 Roche Diagnostics ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 06/18/2009
K031775 ROCHE DIAGNOSTICS CORP. PRECISET DAT PLUS I CALIBRATORS 08/05/2003
K060645 ROCHE DIAGNOSTICS CORP. PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS 05/30/2006
K033306 ROCHE DIAGNOSTICS CORP. PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS 12/15/2003
K031856 ROCHE DIAGNOSTICS CORP. PRECISET TDM I AND PRECISET TDM II CALIBRATORS 08/06/2003
K141928 Roche Diagnostics Operations (RDO) COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR 11/25/2014
K090900 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 06/01/2009
K871174 SUPELCO, INC. 4-9295 BARBITURATES TEST MIX 06/11/1987
K811674 SUPELCO, INC. DRUG STANDARDS 07/15/1981
K833276 SUPELCO, INC. DRUG STANDARDS 01/01/1984
K823740 SYVA CO. ADVANCE SYSTEM EMITAED ANTIEPILEPTIC 01/05/1983
K820190 SYVA CO. CALIBRATOR SET 02/12/1982
K904764 SYVA CO. EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) 11/20/1990
K843163 SYVA CO. EMIT 700 CALIBRATOR A 09/12/1984
K843507 SYVA CO. EMIT 700 CALIBRATOR B 09/26/1984
K993755 SYVA CO. EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 12/21/1999
K912729 SYVA CO. EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) 07/22/1991
K915003 SYVA CO. EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) 11/29/1991
K842816 SYVA CO. EMIT D.A.U. LOW & MED. CALIBRATORS B 09/05/1984
K901573 SYVA CO. EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B 06/06/1990
K903152 SYVA CO. EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS 08/17/1990
K881943 SYVA CO. EMIT HVA CALIBRATOR KIT 07/08/1988
K935192 SYVA CO. EMIT IIC CALIBRATORS 03/24/1995
K821767 SYVA CO. EMIT ST URINE METHAGUALONE CALIBRATOR 06/25/1982
K902578 SYVA CO. EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2 07/10/1990
K902581 SYVA CO. EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) 07/27/1990
K810464 SYVA CO. EMIT-ST SERUM CALBRATOR 03/06/1981
K820461 SYVA CO. EMIT-ST URINE CALIBRATOR A (#3A319 03/11/1982
K802624 SYVA CO. EMIT-STM URINE CALIBRATORS 11/12/1980
K790735 SYVA CO. EMIT-TOX SERUM CALIBRATORS 05/03/1979
K811620 SYVA CO. EMIT-TOX SERUM CALIBRATORS 06/25/1981
K880705 VERICHEM LABORATORIES, INC. THERAPEUTIC DRUG STANDARD 05/31/1988
K881320 VERICHEM LABORATORIES, INC. URINE TOXICOLOGY STANDARD 09/09/1988


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