FDA 510(k) Applications for Medical Device Product Code "DAP"
(Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K890189 AGEN BIOMEDICAL LTD. AGEN DIMERTEST EIA 03/03/1989
K974596 AGEN BIOMEDICAL LTD. DIMERTEST LATEX ASSAY 05/26/1998
K882944 AGEN BIOMEDICAL LTD. DIMERTEST(R) LATEX 08/17/1988
K862156 AMERICAN BIOPRODUCTS CO. ASSERACHROM D-DI KIT 09/16/1986
K920943 AMERICAN BIOPRODUCTS CO. FDP PLASMA TEST KIT 07/13/1992
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
K872195 AMERICAN DADE DATA-FI DIMERTEST LATEX ASSAY 08/06/1987
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
K915503 CALA DIAGNOSTICS FIBRINOGEN FDP CONTROL 01/30/1992
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
K932657 MORE DIAGNOSTICS FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 11/02/1993
K943571 MORE DIAGNOSTICS MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS 06/15/1995
K943787 ORGANON TEKNIKA CORP. AURATEK FDP 09/20/1994
K912876 ORGANON TEKNIKA CORP. FIBRINOSTIKA FBDP MICROELISA SYSTEM 10/09/1991
K915698 ORGANON TEKNIKA CORP. FIBRINOSTIKA TDP MICROELISA SYSTEM 08/05/1992
K974776 ORGANON TEKNIKA CORP. MDA D-DIMER 04/16/1998
K000492 ORGANON TEKNIKA CORP. MDA D-DIMER 06/07/2000
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
K915203 WELLCOME DIAGNOSTICS D-DIMER WELLCOTEST (HA10) 01/31/1992
K012755 XTRANA, INC. AUTODIMER ASSAY MODEL # 1431 03/15/2002


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