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 Innotron of Oregon, Inc..

123
Total
123
Cleared
59d
Avg days
1977
Since
123 devices
25–48 of 123
Cleared Aug 28, 1997
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
K972433
Boehringer Mannheim Corp.
Toxicology · 24d
Cleared May 12, 1997
INNOFLOUR CALIBRATOR REAGENT SET
K970509
Oxis Intl., Inc.
Toxicology · 90d
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 Mar 19, 1996
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
K940048
Solarcare Technologies Corp,Inc.
Toxicology · 804d
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