FDA 510(k) Applications for Medical Device Product Code "DLJ"
(Calibrators, Drug Specific)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| 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 |
| 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 |
| K981926 | EMD CHEMICALS INC. | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | 07/22/1998 |
| 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 |
| K012109 | MICROGENICS CORP. | DRI ECSTASY URINE CALIBRATORS | 08/27/2001 |
| K023780 | MICROGENICS CORP. | DRI PRIMIDONE CALIBRATORS | 02/10/2003 |
| 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 |
| K961726 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 | 07/11/1996 |
| K962280 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR | 08/16/1996 |
| 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 |
| K940048 | SOLARCARE TECHNOLOGIES CORP,INC. | STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION | 03/19/1996 |
| K091617 | Thermo Fisher Scientific | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | 07/17/2009 |
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