DKB · Class II · 21 CFR 862.3200

FDA Product Code DKB: Calibrators, Drug Mixture

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

94
Total
94
Cleared
74d
Avg days
1979
Since

FDA 510(k) Cleared Calibrators, Drug Mixture Devices (Product Code DKB)

94 devices
1–24 of 94
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162
Dade Behring, Inc.
Toxicology · 48d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121
Dade Behring, Inc.
Chemistry · 31d
Cleared May 30, 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K060645
Roche Diagnostics Corp.
Toxicology · 81d
Cleared Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574
Dade Behring, Inc.
Toxicology · 47d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
K031775
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Jan 11, 2000
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
K993954
Beckman Coulter, Inc.
Toxicology · 50d
Cleared Dec 21, 1999
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755
Syva Co.
Toxicology · 46d
Cleared Feb 16, 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255
Dade Behring, Inc.
Toxicology · 20d
Cleared Dec 30, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
K983747
Beckman Coulter, Inc.
Toxicology · 68d
Cleared Nov 04, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209
Beckman Coulter, Inc.
Toxicology · 51d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871
Dade Behring, Inc.
Toxicology · 60d
Cleared May 08, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403
Beckman Instruments, Inc.
Toxicology · 21d
Cleared Apr 21, 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
K980853
Boehringer Mannheim Corp.
Toxicology · 47d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287
Beckman Instruments, Inc.
Toxicology · 31d
Cleared Sep 10, 1996
CEDIA ANTIBIOTIC TDM MULTI-CALS
K963191
Boehringer Mannheim Corp.
Toxicology · 26d
Cleared Dec 26, 1995
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608
Boehringer Mannheim Corp.
Chemistry · 83d
Cleared Mar 24, 1995
EMIT IIC CALIBRATORS
K935192
Syva Co.
Chemistry · 514d
Cleared Feb 22, 1995
DRUGS OF ABUSE CALIBRATOR
K950139
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
K942048
Roche Diagnostic Systems, Inc.
Chemistry · 159d
Cleared Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
K931124
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753
Roche Diagnostic Systems, Inc.
Toxicology · 55d

About Product Code DKB - Regulatory Context