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 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
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 07, 1987
DIGOXIN FPIA CALIBRATORS
K872328
Sigma Chemical Co.
Chemistry · 20d
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 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