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
97–120 of 123
Cleared Sep 26, 1984
EMIT 700 CANNABINOID CALIBRATOR
K843420
Syva Co.
Toxicology · 26d
Cleared Sep 14, 1984
AMIKACIN CALIBRATOR ACA
K843210
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 30d
Cleared Jun 22, 1984
EMIT D.A.U. URINE CANNABINOID CALIBRA
K834457
Syva Co.
Toxicology · 186d
Cleared May 16, 1984
DUPONT THEOPHYLLINE DIT CALIBRATOR
K841655
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Apr 19, 1984
ACA DIGOXIN CALLIBRATOR
K841108
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Mar 23, 1984
QUINIDINE CALIBRATOR
K840597
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 43d
Cleared Mar 19, 1984
SERALYZER DRUG ASSAY CONTROL SERUM
K833977
Miles Laboratories, Inc.
Toxicology · 123d
Cleared Dec 27, 1983
LIDOAINE CALIBRATOR
K833380
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
VALPROIC ACID CALIBRATOR
K833382
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
PROCAINAMIDE CALIBRATOR
K833383
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Oct 27, 1983
ACA TOBRAMYCIN CALIBRATOR
K832982
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Jul 19, 1983
THEOPHYLLINE ACA CALIBRATOR
K831933
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 34d
Cleared Jul 19, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA
K831980
Syva Co.
Toxicology · 29d
Cleared May 16, 1983
GENTAMICIN CALIBRATOR -ACA
K831209
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared Sep 21, 1982
ADVANCE EMIT-CAD QUINIDINE CONTROL
K822587
Syva Co.
Toxicology · 26d
Cleared Jul 27, 1982
EMIT D.A.V. METHAQUALONE URINE CALIBRA
K822052
Syva Co.
Toxicology · 14d
Cleared Aug 20, 1981
EMIT-ST CANNABINOID CALIBRATOR
K812197
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
EMIT-ST SERUM PHENOBARBITAL CALIBRATOR
K811622
Syva Co.
Toxicology · 17d
Cleared Feb 26, 1980
EMIT -D.A.U. CANNABINOID URINE CALIBS.
K800247
Syva Co.
Toxicology · 21d
Cleared Jun 15, 1979
EMIT-D.A.U. PHENCYCLIDINE URINE LOW
K790398
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
URINE MEDIUM CALIBRATOR
K790399
Syva Co.
Toxicology · 109d
Cleared Jan 17, 1979
LIDOCAINE CALIBRATOR KIT
K780731
Vitek Systems, Inc.
Toxicology · 260d
Cleared Nov 22, 1978
PROCAINAMIDE CALIBRATOR KIT
K780732
Vitek Systems, Inc.
Toxicology · 204d
Cleared Nov 22, 1977
EMIT THEOPHYLLINE CONTROL
K772166
Syva Co.
Toxicology · 6d