DKB · Class II · 21 CFR 862.3200

FDA Product Code DKB: Calibrators, Drug Mixture

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Diagnostic Reagents, Inc..

94
Total
94
Cleared
74d
Avg days
1979
Since
94 devices
49–72 of 94
Cleared Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Jul 22, 1993
ABUSCREEN CALIBRATION STANDARD
K932754
Roche Diagnostic Systems, Inc.
Toxicology · 55d
Cleared Aug 04, 1992
ROCHE ABUSCREEN ONLINNE CALIBRATORS
K923340
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Mar 04, 1992
URINE A CALIBRATOR
K920208
Diagnostic Reagents, Inc.
Toxicology · 48d
Cleared Nov 29, 1991
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
K915003
Syva Co.
Toxicology · 22d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET B
K913740
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET C
K913741
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Sep 10, 1991
IL TEST(TM) DAT CALIBRATOR A( -)
K913739
Instrumentation Laboratory CO
Toxicology · 21d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
K913335
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Jul 22, 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
K912729
Syva Co.
Toxicology · 32d
Cleared Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Feb 04, 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Nov 20, 1990
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
K904764
Syva Co.
Toxicology · 29d
Cleared Aug 17, 1990
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
K903152
Syva Co.
Toxicology · 30d
Cleared Jul 27, 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
K902581
Syva Co.
Toxicology · 46d
Cleared Jul 10, 1990
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
K902578
Syva Co.
Toxicology · 29d
Cleared Jun 06, 1990
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
K901573
Syva Co.
Toxicology · 63d
Cleared Oct 17, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
K894934
Hycor Biomedical, Inc.
Toxicology · 75d
Cleared Jul 25, 1989
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
K893815
Hycor Biomedical, Inc.
Toxicology · 63d
Cleared May 11, 1989
DRUGS OF ABUSE URINE CALIBRATORS
K892332
Hycor Biomedical, Inc.
Toxicology · 36d
Cleared Feb 17, 1989
DRUG STANDARD SET
K884177
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Jul 08, 1988
EMIT HVA CALIBRATOR KIT
K881943
Syva Co.
Toxicology · 60d
Cleared Sep 14, 1987
ACA URINE DRUGS OF ABUSE CALIBRATOR
K872392
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 87d