| HemosIL D-Dimer HS 500 (K172903) | Instrumentation Laboratory CO | 2017-11-22 |
| STA® - Liatest® D-Di (K162227) | Diagnostica Stago | 2016-12-10 |
| HemosIL D-Dimer HS (K160885) | Instrumentation Laboratory CO | 2016-10-27 |
| HemosIL D-Dimer HS (K151534) | Instrumentation Laboratory CO | 2015-07-06 |
| STA LIATEST D-DI (K141144) | Diagnostica Stago | 2014-09-03 |
| VIDAS D-DIMER EXCLUSION II (DEX2) (K112818) | bioMerieux, Inc. | 2012-07-31 |
| STRATUS CS ACUTE CARE D-DIMER (K110303) | Siemens Healthcare Diagnostics | 2011-05-16 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K093626) | Siemens Healthcare Diagnostics | 2010-11-29 |
| HEMOSIL D-DIMER HS 500, CONTROLS (K090264) | Instrumentation Laboratory CO | 2010-02-05 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K091916) | Siemens Healthcare Diagnostics | 2009-10-29 |
| INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (K081732) | Siemens Healthcare Diagnostics | 2008-10-24 |
| HEMOSIL D-DIMER (K073042) | Instrumentation Laboratory | 2008-07-31 |
| DIMERTEST (K080069) | American Diagnostica, Inc. | 2008-02-13 |
| HEMOSIL D-DIMER HS (K070927) | Instrumentation Laboratory CO | 2007-09-17 |
| STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK (K063356) | Dade Behring, Inc. | 2007-03-23 |
| STRATUS CS D-DIMER (K051597) | Dade Behring, Inc. | 2005-08-17 |
| HEMOSIL D-DIMER HS (K050544) | Instrumentation Laboratory CO | 2005-04-26 |
| HEMOSIL D-DIMER (K050278) | Instrumentation Laboratory CO | 2005-03-10 |
| TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 (K042723) | Biosite Incorporated | 2004-12-07 |
| ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS (K033491) | Roche Diagnostics Corp. | 2004-09-01 |
| ADVANCED D-DIMER ASSAY (K041438) | Dade Behring, Inc. | 2004-08-11 |
| TRIAGE PROFILER S.O.B. PANEL (K040437) | Biosite Incorporated | 2004-06-25 |
| VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 (K040882) | bioMerieux, Inc. | 2004-06-10 |
| QUANTEX D-DIMER (K032419) | Instrumentation Laboratory CO | 2003-10-24 |
| VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 (K030328) | bioMerieux, Inc. | 2003-09-02 |
| K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (K030687) | Kamiya Biomedical Co. | 2003-06-27 |
| STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D (K022976) | Dade Behring, Inc. | 2003-01-16 |
| STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C (K022977) | Dade Behring, Inc. | 2002-11-27 |
| VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 (K020810) | bioMerieux, Inc. | 2002-10-03 |
| AUTODIMER ASSAY MODEL # 1431 (K012755) | Xtrana, Inc. | 2002-03-15 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (K013549) | Sigma Diagnostics, Inc. | 2001-12-26 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (K013545) | Sigma Diagnostics, Inc. | 2001-11-15 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (K013544) | Sigma Diagnostics, Inc. | 2001-11-15 |
| K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT (K002948) | Kamiya Biomedical Co. | 2001-05-18 |
| ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI (K002706) | Roche Diagnostics Corp. | 2001-03-16 |
| SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (K003267) | Sigma Diagnostics, Inc. | 2001-03-15 |
| MINIQUANT D-DIMER, MODEL 1447 (K002642) | Biopool Intl., Inc. | 2001-02-05 |
| MDA D-DIMER (K000492) | Organon Teknika Corp. | 2000-06-07 |
| ADVANCED D-DIMER (K992957) | Dade Behring, Inc. | 2000-01-28 |
| DIMERTEST LATEX ASSAY (K974596) | Agen Biomedical , Ltd. | 1998-05-26 |
| MDA D-DIMER (K974776) | Organon Teknika Corp. | 1998-04-16 |
| VIDAS D-DIMER (DD) ASSAY (K973819) | Biomerieux Vitek, Inc. | 1998-03-10 |
| IL TEST D-DIMER (K972696) | Instrumentation Laboratory CO | 1997-11-04 |
| STA-LIATEST D-DI TEST KIT (K964728) | American Bioproducts Co. | 1997-06-26 |
| STA D-DI CALIBRATOR KIT (K964718) | American Bioproducts Co. | 1997-05-23 |
| MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS (K943571) | More Diagnostics | 1995-06-15 |
| AURATEK FDP (K943787) | Organon Teknika Corp. | 1994-09-20 |
| FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 (K932657) | More Diagnostics | 1993-11-02 |
| FIBRINOSTIKA TDP MICROELISA SYSTEM (K915698) | Organon Teknika Corp. | 1992-08-05 |
| FDP PLASMA TEST KIT (K920943) | American Bioproducts Co. | 1992-07-13 |
| D-DIMER WELLCOTEST (HA10) (K915203) | Wellcome Diagnostics | 1992-01-31 |
| FIBRINOGEN FDP CONTROL (K915503) | Cala Diagnostics | 1992-01-30 |
| FIBRINOSTIKA FBDP MICROELISA SYSTEM (K912876) | Organon Teknika Corp. | 1991-10-09 |
| AGEN DIMERTEST EIA (K890189) | Agen Biomedical , Ltd. | 1989-03-03 |
| DIMERTEST(R) LATEX (K882944) | Agen Biomedical , Ltd. | 1988-08-17 |
| DATA-FI DIMERTEST LATEX ASSAY (K872195) | American Dade | 1987-08-06 |
| ASSERACHROM D-DI KIT (K862156) | American Bioproducts Co. | 1986-09-16 |