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
123 devices
25–48 of 123
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 Feb 09, 1996
CEDIA DAU LSD CALBIRATORS
K955813
Microgenics Corp.
Toxicology · 45d
Cleared Apr 21, 1995
CEDIA DAU PPX/METH CALIBRATOR
K951153
Microgenics Corp.
Toxicology · 38d
Cleared Jan 17, 1995
THEOPHYLLINE CALIBRATORS
K945338
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Jan 04, 1995
PHENOBARBITAL CALIBRATORS
K945316
Diagnostic Reagents, Inc.
Toxicology · 64d
Cleared Dec 07, 1994
PHENYTOIN CALIBRATORS
K945337
Diagnostic Reagents, Inc.
Toxicology · 36d
Cleared Apr 06, 1994
CEDIA DAU THC CALIBRATORS
K935795
Microgenics Corp.
Toxicology · 120d
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 28, 1993
URINE CALIBRATOR AND CONTROL
K931506
Diagnostic Reagents, Inc.
Toxicology · 125d
Cleared Sep 14, 1992
THC URINE CALIBRATORS
K923386
Diagnostic Reagents, Inc.
Toxicology · 75d
Cleared Mar 18, 1992
THC URINE CALIBRATORS
K920749
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Jan 15, 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464
Sigma Diagnostics, Inc.
Toxicology · 44d
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
Cleared Oct 26, 1990
DUPONT DRUG CLIBRATOR-B
K904303
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Oct 12, 1990
DUPONT ALCOHOL CALIBRATOR
K904308
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared May 16, 1989
ACA VANCOMYCIN CALIBRATOR
K892901
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Feb 10, 1989
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
K890451
Syva Co.
Toxicology · 11d