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

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

94 devices
1–24 of 94
Cleared Nov 25, 2014
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
K141928
Roche Diagnostics Operations (Rdo)
Chemistry · 132d
Cleared Feb 21, 2014
LZI MULTIPLE ANALYTE SET A
K133710
Lin-Zhi International, Inc.
Toxicology · 79d
Cleared Dec 13, 2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
K120936
Microgenics Corporation
Toxicology · 260d
Cleared May 09, 2011
RANDOX METHAMPHETAMINE ASSAY
K092266
Randox Laboratories, Ltd.
Toxicology · 650d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752
Microgenics Corp.
Chemistry · 290d
Cleared Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
K090939
Roche Diagnostics
Chemistry · 76d
Cleared Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900
Siemens Healthcare Diagnostics
Toxicology · 61d
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 Jun 24, 2005
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K051088
Lin-Zhi International, Inc.
Chemistry · 57d
Cleared Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879
Maine Standards Co.
Toxicology · 74d
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 Jun 13, 2002
PRECISET DAT PLUS
K021393
Quantimetrix Corp.
Toxicology · 42d
Cleared Jan 29, 2002
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
K013959
Bayer Diagnostics Corp.
Toxicology · 60d
Cleared Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318
Randox Laboratories, Ltd.
Toxicology · 51d
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 05, 1998
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159
Diagnostic Reagents, Inc.
Toxicology · 57d

About Product Code DKB - Regulatory Context