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 |