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 Dec 26, 1990
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
K904569
Syva Co.
Toxicology · 78d
Cleared Nov 06, 1990
DUPONT SALICYLATE CALIBRATOR
K904307
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 48d
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 Aug 22, 1990
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET
K903101
Innotron of Oregon, Inc.
Toxicology · 40d
Cleared Oct 30, 1989
N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT
K895572
Tudor Laboratories, Inc.
Toxicology · 54d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN CALIBRATOR SET
K895826
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Sep 28, 1989
PRIMIDONE (FPIA) CALIBRATOR KIT
K895568
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 28, 1989
VALPROIC ACID (FPIA) CALIBRATOR KIT
K895570
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 25, 1989
FPR DIGOXIN CALIBRATOR KIT
K894522
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 18, 1989
FPR THEOPHYLLINE CALIBRATOR KIT
K894530
Colony Laboratories, Inc.
Toxicology · 60d
Cleared Sep 01, 1989
FPR TOBRAMYCIN CALIBRATOR KIT
K894532
Colony Laboratories, Inc.
Toxicology · 43d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE CALIBRATOR KIT
K894520
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL CALIBRATOR KIT
K894526
Colony Laboratories, Inc.
Toxicology · 39d
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 Nov 16, 1988
ANALYST THEOPHYLLINE CALIBRATOR
K884170
The DU Pont Co.
Toxicology · 56d
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