FDA 510(k) Applications for Medical Device Product Code "DLJ"
(Calibrators, Drug Specific)

FDA 510(k) Number Applicant Device Name Decision Date
K862964 AMERICAN MONITOR CORP. "ANTIASTHMATIC CALIBRATORS" 08/19/1986
K872181 AMERICAN MONITOR CORP. ETHANOL CALIBRATOR 07/21/1987
K993473 BECKMAN COULTER, INC. SYNCHRON SYSTEMS DRUG CALIBRATOR 2 11/26/1999
K993022 BECKMAN COULTER, INC. SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS 11/09/1999
K972433 BOEHRINGER MANNHEIM CORP. CEDIA DIGOXIN CALIBRATORS 07/24/1997
K894520 COLONY LABORATORIES, INC. FPR CARBAMAZEPINE CALIBRATOR KIT 08/28/1989
K894522 COLONY LABORATORIES, INC. FPR DIGOXIN CALIBRATOR KIT 09/25/1989
K894526 COLONY LABORATORIES, INC. FPR PHENOBARBITAL CALIBRATOR KIT 08/28/1989
K894530 COLONY LABORATORIES, INC. FPR THEOPHYLLINE CALIBRATOR KIT 09/18/1989
K894532 COLONY LABORATORIES, INC. FPR TOBRAMYCIN CALIBRATOR KIT 09/01/1989
K011112 DADE BEHRING, INC. CYCLOSPORINE CALIBRATOR 07/17/2001
K053108 DADE BEHRING, INC. DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 02/16/2006
K061503 DADE BEHRING, INC. DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) 06/22/2006
K052015 DADE BEHRING, INC. DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 09/12/2005
K060503 DADE BEHRING, INC. DIMENSION TACR CALIBRATOR, MODEL DC107 05/18/2006
K062199 DADE BEHRING, INC. DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) 09/06/2006
K062182 DADE BEHRING, INC. DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 09/14/2006
K020845 DADE BEHRING, INC. EMIT 2000 VANCOMYCIN CALIBRATORS 05/08/2002
K972835 DIAGNOSTIC REAGENTS, INC. 50NG/ML COCAINE METABOLITE CALIBRATOR 08/28/1997
K945316 DIAGNOSTIC REAGENTS, INC. PHENOBARBITAL CALIBRATORS 01/04/1995
K945337 DIAGNOSTIC REAGENTS, INC. PHENYTOIN CALIBRATORS 12/07/1994
K920749 DIAGNOSTIC REAGENTS, INC. THC URINE CALIBRATORS 03/18/1992
K923386 DIAGNOSTIC REAGENTS, INC. THC URINE CALIBRATORS 09/14/1992
K945338 DIAGNOSTIC REAGENTS, INC. THEOPHYLLINE CALIBRATORS 01/17/1995
K931506 DIAGNOSTIC REAGENTS, INC. URINE CALIBRATOR AND CONTROL 07/28/1993
K771799 E.I. DUPONT DE NEMOURS & CO., INC. ACA ALCOHOL CALIBRATORS 10/04/1977
K841108 E.I. DUPONT DE NEMOURS & CO., INC. ACA DIGOXIN CALLIBRATOR 04/19/1984
K771805 E.I. DUPONT DE NEMOURS & CO., INC. ACA SALICYLATE CALIBRATOR 10/04/1977
K832982 E.I. DUPONT DE NEMOURS & CO., INC. ACA TOBRAMYCIN CALIBRATOR 10/27/1983
K892901 E.I. DUPONT DE NEMOURS & CO., INC. ACA VANCOMYCIN CALIBRATOR 05/16/1989
K843210 E.I. DUPONT DE NEMOURS & CO., INC. AMIKACIN CALIBRATOR ACA 09/14/1984
K884745 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT ACA METHOTREXATE CALIBRATOR 01/30/1989
K850457 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT DIGOXIN ASSAY CALIBRATOR 03/05/1985
K850059 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT GENTAMICIN ASSAY CALIBRATOR 01/18/1985
K850057 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT TOBRAMYCIN ASSAY CALIBRATOR 01/18/1985
K934144 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ACA URINE METHADONE CALIBRATOR 11/09/1993
K904308 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ALCOHOL CALIBRATOR 10/12/1990
K904303 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT DRUG CLIBRATOR-B 10/26/1990
K904307 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT SALICYLATE CALIBRATOR 11/06/1990
K841655 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT THEOPHYLLINE DIT CALIBRATOR 05/16/1984
K831209 E.I. DUPONT DE NEMOURS & CO., INC. GENTAMICIN CALIBRATOR -ACA 05/16/1983
K833380 E.I. DUPONT DE NEMOURS & CO., INC. LIDOAINE CALIBRATOR 12/27/1983
K833383 E.I. DUPONT DE NEMOURS & CO., INC. PROCAINAMIDE CALIBRATOR 12/27/1983
K840597 E.I. DUPONT DE NEMOURS & CO., INC. QUINIDINE CALIBRATOR 03/23/1984
K831933 E.I. DUPONT DE NEMOURS & CO., INC. THEOPHYLLINE ACA CALIBRATOR 07/19/1983
K833382 E.I. DUPONT DE NEMOURS & CO., INC. VALPROIC ACID CALIBRATOR 12/27/1983
K873436 EM DIAGNOSTIC SYSTEMS, INC. EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 10/29/1987
K871330 EM DIAGNOSTIC SYSTEMS, INC. EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 04/22/1987
K881337 EM DIAGNOSTIC SYSTEMS, INC. EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 05/27/1988
K874101 EM DIAGNOSTIC SYSTEMS, INC. EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 11/09/1987
K874102 EM DIAGNOSTIC SYSTEMS, INC. EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 11/05/1987
K870247 EM DIAGNOSTIC SYSTEMS, INC. EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93 02/11/1987
K981926 EMD CHEMICALS INC. ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS 07/22/1998
K903101 INNOTRON OF OREGON, INC. INNOFLUOR (TM) AMIKACIN CALIBRATOR SET 08/22/1990
K872349 INNOTRON OF OREGON, INC. INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET 07/21/1987
K893506 INNOTRON OF OREGON, INC. INNOFLUOR CARBAMAZEPINE CALIBRATOR SET 08/15/1989
K895826 INNOTRON OF OREGON, INC. INNOFLUOR DIGOXIN CALIBRATOR SET 10/30/1989
K872142 INNOTRON OF OREGON, INC. INNOFLUOR PHENYTOIN CALIBRATOR SET 07/21/1987
K872644 INNOTRON OF OREGON, INC. INNOFLUOR VANCOMYCIN CALIBRATOR SET 07/21/1987
K872462 INNOTRON OF OREGON, INC. INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET 07/21/1987
K872461 INNOTRON OF OREGON, INC. INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET 07/21/1987
K892212 INNOTRON OF OREGON, INC. INNOFLUOR(TM) QUINDINE CALIBATOR SET 06/09/1989
K872463 INNOTRON OF OREGON, INC. INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET 07/21/1987
K911466 INTL. BIOCLINICAL, INC. INNOFLUOR VALPROIC ACID CALIBRATOR SET 05/23/1991
K913186 INTL. BIOCLINICAL, INC. INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET 08/30/1991
K033601 LABONE, INC. LABONE MICRO-PLATE COTININE EIA 02/10/2004
K021449 Lin-Zhi International, Inc. CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS 06/18/2002
K020769 Lin-Zhi International, Inc. SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS 04/03/2002
K023316 Lin-Zhi International, Inc. SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS 12/16/2002
K955813 MICROGENICS CORP. CEDIA DAU LSD CALBIRATORS 02/09/1996
K951153 MICROGENICS CORP. CEDIA DAU PPX/METH CALIBRATOR 04/21/1995
K935795 MICROGENICS CORP. CEDIA DAU THC CALIBRATORS 04/06/1994
K012109 MICROGENICS CORP. DRI ECSTASY URINE CALIBRATORS 08/27/2001
K023780 MICROGENICS CORP. DRI PRIMIDONE CALIBRATORS 02/10/2003
K833977 MILES LABORATORIES, INC. SERALYZER DRUG ASSAY CONTROL SERUM 03/19/1984
K970509 OXIS INTL., INC. INNOFLOUR CALIBRATOR REAGENT SET 05/12/1997
K132090 RANDOX LABORATORIES, LTD. BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 08/08/2013
K983555 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE BENZ 200 CALIBRATORS 12/15/1998
K983556 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE BENZ 300 CALIBRATORS 12/15/1998
K933279 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR 08/09/1993
K961726 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 07/11/1996
K910086 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS 01/17/1991
K932548 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS 12/29/1993
K962280 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR 08/16/1996
K912048 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS 07/26/1991
K033165 ROCHE DIAGNOSTICS CORP. PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS 10/14/2003
K033246 ROCHE DIAGNOSTICS CORP. PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS 12/02/2003
K973536 SCHIAPPARELLI BIOSYSTEMS, INC. ACE PHENOBARBITAL REAGENT/AED CALIBRATORS 11/06/1997
K082030 Siemens Healthcare Diagnostics Inc. DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 08/22/2008
K872328 SIGMA CHEMICAL CO. DIGOXIN FPIA CALIBRATORS 07/07/1987
K915464 SIGMA DIAGNOSTICS, INC. DIGITOXIN FPIA CALIBRATOR SET 01/15/1992
K871423 SIGMA DIAGNOSTICS, INC. PHENYTOIN FPIA CALIBRATORS 06/11/1987
K871394 SIGMA DIAGNOSTICS, INC. THEOPHYLLINE FPIA CALIBRATORS 06/01/1987
K940048 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION 03/19/1996
K822587 SYVA CO. ADVANCE EMIT-CAD QUINIDINE CONTROL 09/21/1982
K800247 SYVA CO. EMIT -D.A.U. CANNABINOID URINE CALIBS. 02/26/1980
K875135 SYVA CO. EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL 04/05/1988
K843420 SYVA CO. EMIT 700 CANNABINOID CALIBRATOR 09/26/1984
K861395 SYVA CO. EMIT COLUMN DIGOXIN CALIBRATORS 05/07/1986
K883920 SYVA CO. EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A 10/11/1988
K834457 SYVA CO. EMIT D.A.U. URINE CANNABINOID CALIBRA 06/22/1984
K822052 SYVA CO. EMIT D.A.V. METHAQUALONE URINE CALIBRA 07/27/1982
K772167 SYVA CO. EMIT LIDOCAINE CONTROL 11/22/1977
K831980 SYVA CO. EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA 07/19/1983
K772166 SYVA CO. EMIT THEOPHYLLINE CONTROL 11/22/1977
K890451 SYVA CO. EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR 02/10/1989
K890452 SYVA CO. EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR 02/10/1989
K904569 SYVA CO. EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS 12/26/1990
K790398 SYVA CO. EMIT-D.A.U. PHENCYCLIDINE URINE LOW 06/15/1979
K812197 SYVA CO. EMIT-ST CANNABINOID CALIBRATOR 08/20/1981
K811622 SYVA CO. EMIT-ST SERUM PHENOBARBITAL CALIBRATOR 06/25/1981
K790399 SYVA CO. URINE MEDIUM CALIBRATOR 06/15/1979
K884170 THE DU PONT CO. ANALYST THEOPHYLLINE CALIBRATOR 11/16/1988
K091617 Thermo Fisher Scientific QMS LIDOCAINE CALIBRATORS, MODEL 0374678 07/17/2009
K895572 TUDOR LABORATORIES, INC. N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT 10/30/1989
K895568 TUDOR LABORATORIES, INC. PRIMIDONE (FPIA) CALIBRATOR KIT 09/28/1989
K895570 TUDOR LABORATORIES, INC. VALPROIC ACID (FPIA) CALIBRATOR KIT 09/28/1989
K780731 VITEK SYSTEMS, INC. LIDOCAINE CALIBRATOR KIT 01/17/1979
K780732 VITEK SYSTEMS, INC. PROCAINAMIDE CALIBRATOR KIT 11/22/1978
K863244 WINDSOR LABORATORIES, INC. AMIKACIN (FPIA) CALIBRATOR KIT 08/29/1986
K873281 WINDSOR LABORATORIES, INC. CARBAMAZEPINE (FPIA) CALIBRATOR KIT 10/28/1987
K870389 WINDSOR LABORATORIES, INC. DIGOXIN (FPIA) CALIBRATOR KIT 04/01/1987
K870390 WINDSOR LABORATORIES, INC. PHENOBARBITAL (FPIA) CALIBRATOR KIT 04/01/1987


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