DLJ · Class II · 21 CFR 862.3200

FDA Product Code DLJ: Calibrators, Drug Specific

Leading manufacturers include E.I. Dupont DE Nemours & Co., Inc., Syva Co. and Roche Diagnostic Systems, Inc..

123
Total
123
Cleared
59d
Avg days
1977
Since

FDA 510(k) Cleared Calibrators, Drug Specific Devices (Product Code DLJ)

123 devices
1–24 of 123
Cleared Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
K132090
Randox Laboratories, Ltd.
Toxicology · 27d
Cleared Jul 17, 2009
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
K091617
Thermo Fisher Scientific
Toxicology · 44d
Cleared Aug 22, 2008
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030
Siemens Healthcare Diagnostics, Inc.
Toxicology · 36d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182
Dade Behring, Inc.
Toxicology · 45d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199
Dade Behring, Inc.
Toxicology · 36d
Cleared Jun 22, 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503
Dade Behring, Inc.
Toxicology · 21d
Cleared May 18, 2006
DIMENSION TACR CALIBRATOR, MODEL DC107
K060503
Dade Behring, Inc.
Toxicology · 83d
Cleared Feb 16, 2006
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
K053108
Dade Behring, Inc.
Chemistry · 104d
Cleared Sep 12, 2005
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
K052015
Dade Behring, Inc.
Toxicology · 48d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780
Microgenics Corp.
Toxicology · 90d
Cleared Dec 16, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K023316
Lin-Zhi International, Inc.
Toxicology · 74d
Cleared Jun 18, 2002
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449
Lin-Zhi International, Inc.
Toxicology · 43d
Cleared May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845
Dade Behring, Inc.
Toxicology · 54d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769
Lin-Zhi International, Inc.
Toxicology · 27d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109
Microgenics Corp.
Toxicology · 52d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112
Dade Behring, Inc.
Chemistry · 97d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473
Beckman Coulter, Inc.
Toxicology · 43d
Cleared Nov 09, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
K993022
Beckman Coulter, Inc.
Toxicology · 61d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
K983556
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Jul 22, 1998
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K981926
Emd Chemicals, Inc.
Toxicology · 50d
Cleared Aug 28, 1997
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835
Diagnostic Reagents, Inc.
Toxicology · 28d

About Product Code DLJ - Regulatory Context