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
49–72 of 123
Cleared Oct 12, 1990
DUPONT ALCOHOL CALIBRATOR
K904308
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Aug 22, 1990
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET
K903101
Innotron of Oregon, Inc.
Toxicology · 40d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN CALIBRATOR SET
K895826
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Aug 15, 1989
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET
K893506
Innotron of Oregon, Inc.
Chemistry · 102d
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINDINE CALIBATOR SET
K892212
Innotron of Oregon, Inc.
Toxicology · 67d
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 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