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
73–96 of 123
Cleared Jun 11, 1987
PHENYTOIN FPIA CALIBRATORS
K871423
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
K871394
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330
Em Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Apr 01, 1987
DIGOXIN (FPIA) CALIBRATOR KIT
K870389
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
PHENOBARBITAL (FPIA) CALIBRATOR KIT
K870390
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Aug 29, 1986
AMIKACIN (FPIA) CALIBRATOR KIT
K863244
Windsor Laboratories, Inc.
Toxicology · 7d
Cleared Aug 19, 1986
ANTIASTHMATIC CALIBRATORS
K862964
American Monitor Corp.
Toxicology · 13d
Cleared May 07, 1986
EMIT COLUMN DIGOXIN CALIBRATORS
K861395
Syva Co.
Chemistry · 23d
Cleared Mar 05, 1985
DU PONT DIGOXIN ASSAY CALIBRATOR
K850457
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Jan 18, 1985
DU PONT TOBRAMYCIN ASSAY CALIBRATOR
K850057
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Jan 18, 1985
DU PONT GENTAMICIN ASSAY CALIBRATOR
K850059
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
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