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
49–72 of 123
Cleared Feb 10, 1989
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
K890452
Syva Co.
Toxicology · 11d
Cleared Jan 30, 1989
DU PONT ACA METHOTREXATE CALIBRATOR
K884745
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d
Cleared Oct 11, 1988
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920
Syva Co.
Toxicology · 25d
Cleared May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337
Em Diagnostic Systems, Inc.
Toxicology · 59d
Cleared Apr 05, 1988
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
K875135
Syva Co.
Toxicology · 113d
Cleared Nov 09, 1987
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101
Em Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Nov 05, 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102
Em Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Oct 29, 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jul 21, 1987
ETHANOL CALIBRATOR
K872181
American Monitor Corp.
Toxicology · 43d
Cleared Jul 07, 1987
DIGOXIN FPIA CALIBRATORS
K872328
Sigma Chemical Co.
Chemistry · 20d
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 Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247
Em Diagnostic Systems, Inc.
Chemistry · 21d
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