FDA 510(k) Applications for Medical Device Product Code "DKB"
(Calibrators, Drug Mixture)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013959 | BAYER DIAGNOSTICS CORP. | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS | 01/29/2002 |
| K983209 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I | 11/04/1998 |
| K983747 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II | 12/30/1998 |
| K993954 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS | 01/11/2000 |
| K981403 | BECKMAN INSTRUMENTS, INC. | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | 05/08/1998 |
| K971287 | BECKMAN INSTRUMENTS, INC. | SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS | 05/08/1997 |
| K971600 | BEHRING DIAGNOSTICS, INC. | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | 06/25/1997 |
| K963191 | BOEHRINGER MANNHEIM CORP. | CEDIA ANTIBIOTIC TDM MULTI-CALS | 09/10/1996 |
| K980853 | BOEHRINGER MANNHEIM CORP. | CEDIA DAU MULTI-DRUG CALIBRATORS | 04/21/1998 |
| K974699 | CONSOLIDATED TECHNOLOGIES, INC. | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE | 01/22/1998 |
| K990255 | DADE BEHRING, INC. | DIMENSION DRUG CALIBRATOR II, MODEL DC49B | 02/16/1999 |
| K032574 | DADE BEHRING, INC. | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | 10/06/2003 |
| K062121 | DADE BEHRING, INC. | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) | 08/25/2006 |
| K062162 | DADE BEHRING, INC. | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | 09/14/2006 |
| K982871 | DADE BEHRING, INC. | DRUG CALIBRATOR II | 10/13/1998 |
| K962817 | DADE INTL., INC. | DRUG CALIBRATOR II | 09/16/1996 |
| K961273 | DIAGNOSTIC REAGENTS, INC. | AED CALIBRATORS | 05/15/1996 |
| K983159 | DIAGNOSTIC REAGENTS, INC. | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | 11/05/1998 |
| K961372 | DIAGNOSTIC REAGENTS, INC. | SERUM TOX CALIBRATOR | 05/01/1996 |
| K133710 | Lin-Zhi International, Inc. | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | 02/21/2014 |
| K051088 | Lin-Zhi International, Inc. | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | 06/24/2005 |
| K033879 | MAINE STANDARDS CO. | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | 02/27/2004 |
| K101752 | MICROGENICS CORP. | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | 04/08/2011 |
| K120936 | Microgenics Corporation | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | 12/13/2012 |
| K021393 | QUANTIMETRIX CORP. | PRECISET DAT PLUS | 06/13/2002 |
| K092266 | RANDOX LABORATORIES, LTD. | RANDOX METHAMPHETAMINE ASSAY | 05/09/2011 |
| K012318 | RANDOX LABORATORIES, LTD. | RANDOX THERAPEUTIC DRUG CALIBRATOR | 09/12/2001 |
| K090939 | Roche Diagnostics | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 | 06/18/2009 |
| K031775 | ROCHE DIAGNOSTICS CORP. | PRECISET DAT PLUS I CALIBRATORS | 08/05/2003 |
| K060645 | ROCHE DIAGNOSTICS CORP. | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | 05/30/2006 |
| K033306 | ROCHE DIAGNOSTICS CORP. | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | 12/15/2003 |
| K031856 | ROCHE DIAGNOSTICS CORP. | PRECISET TDM I AND PRECISET TDM II CALIBRATORS | 08/06/2003 |
| K141928 | Roche Diagnostics Operations (RDO) | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | 11/25/2014 |
| K090900 | SIEMENS HEALTHCARE DIAGNOSTICS | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | 06/01/2009 |
| K993755 | SYVA CO. | EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 | 12/21/1999 |
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