Panels › Clinical Toxicology › Product code DLJ · Class 2
Calibrators, Drug Specific
Regulation 862.3200
0510(k)s in 12 months (123 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in DLJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2013 | K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 Randox Laboratories, Ltd., GB | DLJ |
| Jul 17, 2009 | K091617 | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 Thermo Fisher Scientific | DLJ |
| Aug 22, 2008 | K082030 | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 Siemens Healthcare Diagnostics, Inc. | DLJ |
| Sep 14, 2006 | K062182 | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 Dade Behring, Inc. | DLJ |
| Sep 6, 2006 | K062199 | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) Dade Behring, Inc. | DLJ |
| Jun 22, 2006 | K061503 | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) Dade Behring, Inc. | DLJ |
| May 18, 2006 | K060503 | DIMENSION TACR CALIBRATOR, MODEL DC107 Dade Behring, Inc. | DLJ |
| Feb 16, 2006 | K053108 | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 Dade Behring, Inc. | DLJ |
| Sep 12, 2005 | K052015 | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 Dade Behring, Inc. | DLJ |
| Feb 10, 2004 | K033601 | LABONE MICRO-PLATE COTININE EIA Labone, Inc. | DLJ |
| Dec 2, 2003 | K033246 | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS Roche Diagnostics Corp. | DLJ |
| Oct 14, 2003 | K033165 | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS Roche Diagnostics Corp. | DLJ |
| Feb 10, 2003 | K023780 | DRI PRIMIDONE CALIBRATORS Microgenics Corp. | DLJ |
| Dec 16, 2002 | K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLJ |
| Jun 18, 2002 | K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLJ |
| May 8, 2002 | K020845 | EMIT 2000 VANCOMYCIN CALIBRATORS Dade Behring, Inc. | DLJ |
| Apr 3, 2002 | K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLJ |
| Aug 27, 2001 | K012109 | DRI ECSTASY URINE CALIBRATORS Microgenics Corp. | DLJ |
| Jul 17, 2001 | K011112 | CYCLOSPORINE CALIBRATOR Dade Behring, Inc. | DLJ |
| Nov 26, 1999 | K993473 | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 Beckman Coulter, Inc. | DLJ |
| Nov 9, 1999 | K993022 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS Beckman Coulter, Inc. | DLJ |
| Dec 15, 1998 | K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| Dec 15, 1998 | K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| Jul 22, 1998 | K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc. | DLJ |
| Nov 6, 1997 | K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS Schiapparelli Biosystems, Inc. | DLJ |
| Aug 28, 1997 | K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR Diagnostic Reagents, Inc. | DLJ |
| Jul 24, 1997 | K972433 | CEDIA DIGOXIN CALIBRATORS Boehringer Mannheim Corp. | DLJ |
| May 12, 1997 | K970509 | INNOFLOUR CALIBRATOR REAGENT SET Oxis Intl., Inc. | DLJ |
| Aug 16, 1996 | K962280 | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR Roche Diagnostic Systems, Inc. | DLJ |
| Jul 11, 1996 | K961726 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 Roche Diagnostic Systems, Inc. | DLJ |
| Mar 19, 1996 | K940048 | STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION Solarcare Technologies Corp,Inc. | DLJ |
| Feb 9, 1996 | K955813 | CEDIA DAU LSD CALBIRATORS Microgenics Corp. | DLJ |
| Apr 21, 1995 | K951153 | CEDIA DAU PPX/METH CALIBRATOR Microgenics Corp. | DLJ |
| Jan 17, 1995 | K945338 | THEOPHYLLINE CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Jan 4, 1995 | K945316 | PHENOBARBITAL CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Dec 7, 1994 | K945337 | PHENYTOIN CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Apr 6, 1994 | K935795 | CEDIA DAU THC CALIBRATORS Microgenics Corp. | DLJ |
| Dec 29, 1993 | K932548 | ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| Nov 9, 1993 | K934144 | DUPONT ACA URINE METHADONE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DLJ |
| Aug 9, 1993 | K933279 | ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR Roche Diagnostic Systems, Inc. | DLJ |
| Jul 28, 1993 | K931506 | URINE CALIBRATOR AND CONTROL Diagnostic Reagents, Inc. | DLJ |
| Sep 14, 1992 | K923386 | THC URINE CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Mar 18, 1992 | K920749 | THC URINE CALIBRATORS Diagnostic Reagents, Inc. | DLJ |
| Jan 15, 1992 | K915464 | DIGITOXIN FPIA CALIBRATOR SET Sigma Diagnostics, Inc. | DLJ |
| Aug 30, 1991 | K913186 | INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET Intl. Bioclinical, Inc. | DLJ |
| Jul 26, 1991 | K912048 | ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| May 23, 1991 | K911466 | INNOFLUOR VALPROIC ACID CALIBRATOR SET Intl. Bioclinical, Inc. | DLJ |
| Jan 17, 1991 | K910086 | ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| Dec 26, 1990 | K904569 | EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS Syva Co. | DLJ |
| Nov 6, 1990 | K904307 | DUPONT SALICYLATE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DLJ |
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