Panels › Hematology › Product code DAP · Class 2
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation 864.7320
1510(k)s in 12 months (58 all time)
2recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in DAP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2026 | K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) Siemens Healthcare Diagnostic Products GmbH, DE | DAP |
| Nov 22, 2017 | K172903 | HemosIL D-Dimer HS 500 Instrumentation Laboratory CO | DAP |
| Dec 10, 2016 | K162227 | STA® - Liatest® D-Di Diagnostica Stago, FR | DAP |
| Oct 27, 2016 | K160885 | HemosIL D-Dimer HS Instrumentation Laboratory CO | DAP |
| Jul 6, 2015 | K151534 | HemosIL D-Dimer HS Instrumentation Laboratory CO | DAP |
| Sep 3, 2014 | K141144 | STA LIATEST D-DI Diagnostica Stago, IT | DAP |
| Jul 31, 2012 | K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) bioMerieux, Inc. | DAP |
| May 16, 2011 | K110303 | STRATUS CS ACUTE CARE D-DIMER Siemens Healthcare Diagnostics | DAP |
| Nov 29, 2010 | K093626 | INNOVANCE D-DIMER, MODEL OPBP09 Siemens Healthcare Diagnostics | DAP |
| Feb 5, 2010 | K090264 | HEMOSIL D-DIMER HS 500, CONTROLS Instrumentation Laboratory CO | DAP |
| Oct 29, 2009 | K091916 | INNOVANCE D-DIMER, MODEL OPBP09 Siemens Healthcare Diagnostics | DAP |
| Oct 24, 2008 | K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS Siemens Healthcare Diagnostics | DAP |
| Jul 31, 2008 | K073042 | HEMOSIL D-DIMER Instrumentation Laboratory | DAP |
| Feb 13, 2008 | K080069 | DIMERTEST American Diagnostica, Inc. | DAP |
| Sep 17, 2007 | K070927 | HEMOSIL D-DIMER HS Instrumentation Laboratory CO | DAP |
| Mar 23, 2007 | K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK Dade Behring, Inc. | DAP |
| Aug 17, 2005 | K051597 | STRATUS CS D-DIMER Dade Behring, Inc. | DAP |
| Apr 26, 2005 | K050544 | HEMOSIL D-DIMER HS Instrumentation Laboratory CO | DAP |
| Mar 10, 2005 | K050278 | HEMOSIL D-DIMER Instrumentation Laboratory CO | DAP |
| Dec 7, 2004 | K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 Biosite Incorporated | DAP |
| Sep 1, 2004 | K033491 | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS Roche Diagnostics Corp. | DAP |
| Aug 11, 2004 | K041438 | ADVANCED D-DIMER ASSAY Dade Behring, Inc. | DAP |
| Jun 25, 2004 | K040437 | TRIAGE PROFILER S.O.B. PANEL Biosite Incorporated | DAP |
| Jun 10, 2004 | K040882 | VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 bioMerieux, Inc. | DAP |
| Oct 24, 2003 | K032419 | QUANTEX D-DIMER Instrumentation Laboratory CO | DAP |
| Sep 2, 2003 | K030328 | VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 bioMerieux, Inc. | DAP |
| Jun 27, 2003 | K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C Kamiya Biomedical Co. | DAP |
| Jan 16, 2003 | K022976 | STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D Dade Behring, Inc. | DAP |
| Nov 27, 2002 | K022977 | STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C Dade Behring, Inc. | DAP |
| Oct 3, 2002 | K020810 | VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 bioMerieux, Inc. | DAP |
| Mar 15, 2002 | K012755 | AUTODIMER ASSAY MODEL # 1431 Xtrana, Inc. | DAP |
| Dec 26, 2001 | K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 Sigma Diagnostics, Inc. | DAP |
| Nov 15, 2001 | K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 Sigma Diagnostics, Inc. | DAP |
| Nov 15, 2001 | K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 Sigma Diagnostics, Inc. | DAP |
| May 18, 2001 | K002948 | K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT Kamiya Biomedical Co. | DAP |
| Mar 16, 2001 | K002706 | ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI Roche Diagnostics Corp. | DAP |
| Mar 15, 2001 | K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A Sigma Diagnostics, Inc. | DAP |
| Feb 5, 2001 | K002642 | MINIQUANT D-DIMER, MODEL 1447 Biopool Intl., Inc. | DAP |
| Jun 7, 2000 | K000492 | MDA D-DIMER Organon Teknika Corp. | DAP |
| Jan 28, 2000 | K992957 | ADVANCED D-DIMER Dade Behring, Inc. | DAP |
| May 26, 1998 | K974596 | DIMERTEST LATEX ASSAY Agen Biomedical , Ltd., AU | DAP |
| Apr 16, 1998 | K974776 | MDA D-DIMER Organon Teknika Corp. | DAP |
| Mar 10, 1998 | K973819 | VIDAS D-DIMER (DD) ASSAY Biomerieux Vitek, Inc. | DAP |
| Nov 4, 1997 | K972696 | IL TEST D-DIMER Instrumentation Laboratory CO | DAP |
| Jun 26, 1997 | K964728 | STA-LIATEST D-DI TEST KIT American Bioproducts Co. | DAP |
| May 23, 1997 | K964718 | STA D-DI CALIBRATOR KIT American Bioproducts Co. | DAP |
| Jun 15, 1995 | K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS More Diagnostics | DAP |
| Sep 20, 1994 | K943787 | AURATEK FDP Organon Teknika Corp. | DAP |
| Nov 2, 1993 | K932657 | FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 More Diagnostics | DAP |
| Aug 5, 1992 | K915698 | FIBRINOSTIKA TDP MICROELISA SYSTEM Organon Teknika Corp. | DAP |
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