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 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 Oct 28, 1987
CARBAMAZEPINE (FPIA) CALIBRATOR KIT
K873281
Windsor Laboratories, Inc.
Toxicology · 72d
Cleared Jul 21, 1987
INNOFLUOR PHENYTOIN CALIBRATOR SET
K872142
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
ETHANOL CALIBRATOR
K872181
American Monitor Corp.
Toxicology · 43d
Cleared Jul 21, 1987
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
K872349
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET
K872461
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET
K872462
Innotron of Oregon, Inc.
Toxicology · 29d
Cleared Jul 21, 1987
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET
K872463
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
INNOFLUOR VANCOMYCIN CALIBRATOR SET
K872644
Innotron of Oregon, Inc.
Toxicology · 15d
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 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