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 Dade Behring, 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 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 May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845
Dade Behring, Inc.
Toxicology · 54d
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 24, 1997
CEDIA DIGOXIN CALIBRATORS
K972433
Boehringer Mannheim Corp.
Toxicology · 24d
Cleared Aug 16, 1996
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
K962280
Roche Diagnostic Systems, Inc.
Toxicology · 64d
Cleared Jul 11, 1996
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
K961726
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Dec 29, 1993
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548
Roche Diagnostic Systems, Inc.
Toxicology · 217d
Cleared Nov 09, 1993
DUPONT ACA URINE METHADONE CALIBRATOR
K934144
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Aug 09, 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Dec 26, 1990
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
K904569
Syva Co.
Toxicology · 78d
Cleared Nov 06, 1990
DUPONT SALICYLATE CALIBRATOR
K904307
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 48d

About Product Code DLJ - Regulatory Context