FDA Product Code
FDA Product Code DAP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7320
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | 2026-08-11 | Traditional | PDF ↗ |
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | 2017-11-22 | Special | PDF ↗ |
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | 2016-12-10 | Traditional | PDF ↗ |
| K160885 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2016-10-27 | Special | PDF ↗ |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2015-07-06 | Special | PDF ↗ |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | 2014-09-03 | Traditional | PDF ↗ |
| K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | bioMerieux, Inc. | 2012-07-31 | Traditional | PDF ↗ |
| K110303 | STRATUS CS ACUTE CARE D-DIMER | Siemens Healthcare Diagnostics | 2011-05-16 | Traditional | PDF ↗ |
| K093626 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2010-11-29 | Traditional | PDF ↗ |
| K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | Instrumentation Laboratory CO | 2010-02-05 | Traditional | PDF ↗ |
| K091916 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2009-10-29 | Traditional | PDF ↗ |
| K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | Siemens Healthcare Diagnostics | 2008-10-24 | Traditional | PDF ↗ |
| K073042 | HEMOSIL D-DIMER | Instrumentation Laboratory | 2008-07-31 | Traditional | PDF ↗ |
| K080069 | DIMERTEST | American Diagnostica, Inc. | 2008-02-13 | Traditional | PDF ↗ |
| K070927 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2007-09-17 | Traditional | PDF ↗ |
| K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | Dade Behring, Inc. | 2007-03-23 | Traditional | PDF ↗ |
| K051597 | STRATUS CS D-DIMER | Dade Behring, Inc. | 2005-08-17 | Traditional | PDF ↗ |
| K050544 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2005-04-26 | Traditional | PDF ↗ |
| K050278 | HEMOSIL D-DIMER | Instrumentation Laboratory CO | 2005-03-10 | Traditional | PDF ↗ |
| K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | Biosite Incorporated | 2004-12-07 | Traditional | PDF ↗ |
| K033491 | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS | Roche Diagnostics Corp. | 2004-09-01 | Traditional | PDF ↗ |
| K041438 | ADVANCED D-DIMER ASSAY | Dade Behring, Inc. | 2004-08-11 | Traditional | PDF ↗ |
| K040437 | TRIAGE PROFILER S.O.B. PANEL | Biosite Incorporated | 2004-06-25 | Traditional | PDF ↗ |
| K040882 | VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 | bioMerieux, Inc. | 2004-06-10 | Traditional | PDF ↗ |
| K032419 | QUANTEX D-DIMER | Instrumentation Laboratory CO | 2003-10-24 | Traditional | PDF ↗ |
| K030328 | VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 | bioMerieux, Inc. | 2003-09-02 | Traditional | PDF ↗ |
| K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | Kamiya Biomedical Co. | 2003-06-27 | Traditional | PDF ↗ |
| K022976 | STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D | Dade Behring, Inc. | 2003-01-16 | Traditional | PDF ↗ |
| K022977 | STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C | Dade Behring, Inc. | 2002-11-27 | Traditional | PDF ↗ |
| K020810 | VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 | bioMerieux, Inc. | 2002-10-03 | Traditional | PDF ↗ |
| K012755 | AUTODIMER ASSAY MODEL # 1431 | Xtrana, Inc. | 2002-03-15 | Traditional | PDF ↗ |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | Sigma Diagnostics, Inc. | 2001-12-26 | Traditional | PDF ↗ |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | Sigma Diagnostics, Inc. | 2001-11-15 | Traditional | PDF ↗ |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | Sigma Diagnostics, Inc. | 2001-11-15 | Traditional | PDF ↗ |
| K002948 | K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT | Kamiya Biomedical Co. | 2001-05-18 | Traditional | PDF ↗ |
| K002706 | ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI | Roche Diagnostics Corp. | 2001-03-16 | Traditional | PDF ↗ |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Sigma Diagnostics, Inc. | 2001-03-15 | Traditional | PDF ↗ |
| K002642 | MINIQUANT D-DIMER, MODEL 1447 | Biopool Intl., Inc. | 2001-02-05 | Traditional | PDF ↗ |
| K000492 | MDA D-DIMER | Organon Teknika Corp. | 2000-06-07 | Traditional | PDF ↗ |
| K992957 | ADVANCED D-DIMER | Dade Behring, Inc. | 2000-01-28 | Traditional | PDF ↗ |
| K974596 | DIMERTEST LATEX ASSAY | Agen Biomedical , Ltd. | 1998-05-26 | Traditional | PDF ↗ |
| K974776 | MDA D-DIMER | Organon Teknika Corp. | 1998-04-16 | Traditional | PDF ↗ |
| K973819 | VIDAS D-DIMER (DD) ASSAY | Biomerieux Vitek, Inc. | 1998-03-10 | Traditional | PDF ↗ |
| K972696 | IL TEST D-DIMER | Instrumentation Laboratory CO | 1997-11-04 | Traditional | PDF ↗ |
| K964728 | STA-LIATEST D-DI TEST KIT | American Bioproducts Co. | 1997-06-26 | Traditional | PDF ↗ |
| K964718 | STA D-DI CALIBRATOR KIT | American Bioproducts Co. | 1997-05-23 | Traditional | PDF ↗ |
| K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS | More Diagnostics | 1995-06-15 | Traditional | PDF ↗ |
| K943787 | AURATEK FDP | Organon Teknika Corp. | 1994-09-20 | Traditional | PDF ↗ |
| K932657 | FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 | More Diagnostics | 1993-11-02 | Traditional | PDF ↗ |
| K915698 | FIBRINOSTIKA TDP MICROELISA SYSTEM | Organon Teknika Corp. | 1992-08-05 | Traditional | PDF ↗ |
| K920943 | FDP PLASMA TEST KIT | American Bioproducts Co. | 1992-07-13 | Traditional | PDF ↗ |
| K915203 | D-DIMER WELLCOTEST (HA10) | Wellcome Diagnostics | 1992-01-31 | Traditional | PDF ↗ |
| K915503 | FIBRINOGEN FDP CONTROL | Cala Diagnostics | 1992-01-30 | Traditional | PDF ↗ |
| K912876 | FIBRINOSTIKA FBDP MICROELISA SYSTEM | Organon Teknika Corp. | 1991-10-09 | Traditional | PDF ↗ |
| K890189 | AGEN DIMERTEST EIA | Agen Biomedical , Ltd. | 1989-03-03 | Traditional | PDF ↗ |
| K882944 | DIMERTEST(R) LATEX | Agen Biomedical , Ltd. | 1988-08-17 | Traditional | PDF ↗ |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | American Dade | 1987-08-06 | Traditional | PDF ↗ |
| K862156 | ASSERACHROM D-DI KIT | American Bioproducts Co. | 1986-09-16 | Traditional | PDF ↗ |
Product code DAP · Class II · Hematology. Data: openFDA.