FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K974596 |
AGEN BIOMEDICAL LTD. |
DIMERTEST LATEX ASSAY |
05/26/1998 |
K964718 |
AMERICAN BIOPRODUCTS CO. |
STA D-DI CALIBRATOR KIT |
05/23/1997 |
K964728 |
AMERICAN BIOPRODUCTS CO. |
STA-LIATEST D-DI TEST KIT |
06/26/1997 |
K080069 |
AMERICAN DIAGNOSTICA, INC. |
DIMERTEST |
02/13/2008 |
K973819 |
BIOMERIEUX VITEK, INC. |
VIDAS D-DIMER (DD) ASSAY |
03/10/1998 |
K040882 |
BIOMERIEUX, INC. |
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 |
06/10/2004 |
K112818 |
BIOMERIEUX, INC. |
VIDAS D-DIMER EXCLUSION II (DEX2) |
07/31/2012 |
K020810 |
BIOMERIEUX, INC. |
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 |
10/03/2002 |
K030328 |
BIOMERIEUX, INC. |
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 |
09/02/2003 |
K002642 |
BIOPOOL INTL., INC. |
MINIQUANT D-DIMER, MODEL 1447 |
02/05/2001 |
K040437 |
BIOSITE INCORPORATED |
TRIAGE PROFILER S.O.B. PANEL |
06/25/2004 |
K042723 |
BIOSITE INCORPORATED |
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 |
12/07/2004 |
K992957 |
DADE BEHRING, INC. |
ADVANCED D-DIMER |
01/28/2000 |
K041438 |
DADE BEHRING, INC. |
ADVANCED D-DIMER ASSAY |
08/11/2004 |
K063356 |
DADE BEHRING, INC. |
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK |
03/23/2007 |
K051597 |
DADE BEHRING, INC. |
STRATUS CS D-DIMER |
08/17/2005 |
K022976 |
DADE BEHRING, INC. |
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D |
01/16/2003 |
K022977 |
DADE BEHRING, INC. |
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C |
11/27/2002 |
K141144 |
DIAGNOSTICA STAGO |
STA LIATEST D-DI |
09/03/2014 |
K162227 |
Diagnostica Stago |
STA« - Liatest« D-Di |
12/10/2016 |
K073042 |
INSTRUMENTATION LABORATORY |
HEMOSIL D-DIMER |
07/31/2008 |
K050278 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL D-DIMER |
03/10/2005 |
K050544 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL D-DIMER HS |
04/26/2005 |
K070927 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL D-DIMER HS |
09/17/2007 |
K151534 |
INSTRUMENTATION LABORATORY CO. |
HemosIL D-Dimer HS |
07/06/2015 |
K160885 |
INSTRUMENTATION LABORATORY CO. |
HemosIL D-Dimer HS |
10/27/2016 |
K172903 |
Instrumentation Laboratory Co. |
HemosIL D-Dimer HS 500 |
11/22/2017 |
K090264 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL D-DIMER HS 500, CONTROLS |
02/05/2010 |
K972696 |
INSTRUMENTATION LABORATORY CO. |
IL TEST D-DIMER |
11/04/1997 |
K032419 |
INSTRUMENTATION LABORATORY CO. |
QUANTEX D-DIMER |
10/24/2003 |
K002948 |
KAMIYA BIOMEDICAL CO. |
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT |
05/18/2001 |
K030687 |
KAMIYA BIOMEDICAL CO. |
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C |
06/27/2003 |
K000492 |
ORGANON TEKNIKA CORP. |
MDA D-DIMER |
06/07/2000 |
K974776 |
ORGANON TEKNIKA CORP. |
MDA D-DIMER |
04/16/1998 |
K033491 |
ROCHE DIAGNOSTICS CORP. |
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS |
09/01/2004 |
K002706 |
ROCHE DIAGNOSTICS CORP. |
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI |
03/16/2001 |
K081732 |
SIEMENS HEALTHCARE DIAGNOSTICS |
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS |
10/24/2008 |
K093626 |
SIEMENS HEALTHCARE DIAGNOSTICS |
INNOVANCE D-DIMER, MODEL OPBP09 |
11/29/2010 |
K091916 |
SIEMENS HEALTHCARE DIAGNOSTICS |
INNOVANCE D-DIMER, MODEL OPBP09 |
10/29/2009 |
K110303 |
SIEMENS HEALTHCARE DIAGNOSTICS |
STRATUS CS ACUTE CARE D-DIMER |
05/16/2011 |
K013549 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 |
12/26/2001 |
K013544 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 |
11/15/2001 |
K013545 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 |
11/15/2001 |
K003267 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A |
03/15/2001 |
K012755 |
XTRANA, INC. |
AUTODIMER ASSAY MODEL # 1431 |
03/15/2002 |