DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class II
FDA product code DAP covers "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 864.7320. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DAP
- Device Class
- Class II
- Regulation Number
- 864.7320
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172903 | instrumentation laboratory | HemosIL D-Dimer HS 500 | November 22, 2017 |
| K162227 | diagnostica stago | STA® - Liatest® D-Di | December 10, 2016 |
| K160885 | instrumentation laboratory | HemosIL D-Dimer HS | October 27, 2016 |
| K151534 | instrumentation laboratory | HemosIL D-Dimer HS | July 6, 2015 |
| K141144 | diagnostica stago | STA LIATEST D-DI | September 3, 2014 |
| K112818 | biomerieux | VIDAS D-DIMER EXCLUSION II (DEX2) | July 31, 2012 |
| K110303 | siemens healthcare diagnostics | STRATUS CS ACUTE CARE D-DIMER | May 16, 2011 |
| K093626 | siemens healthcare diagnostics | INNOVANCE D-DIMER, MODEL OPBP09 | November 29, 2010 |
| K090264 | instrumentation laboratory | HEMOSIL D-DIMER HS 500, CONTROLS | February 5, 2010 |
| K091916 | siemens healthcare diagnostics | INNOVANCE D-DIMER, MODEL OPBP09 | October 29, 2009 |
| K081732 | siemens healthcare diagnostics | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | October 24, 2008 |
| K073042 | instrumentation laboratory | HEMOSIL D-DIMER | July 31, 2008 |
| K080069 | american diagnostica | DIMERTEST | February 13, 2008 |
| K070927 | instrumentation laboratory | HEMOSIL D-DIMER HS | September 17, 2007 |
| K063356 | dade behring | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | March 23, 2007 |
| K051597 | dade behring | STRATUS CS D-DIMER | August 17, 2005 |
| K050544 | instrumentation laboratory | HEMOSIL D-DIMER HS | April 26, 2005 |
| K050278 | instrumentation laboratory | HEMOSIL D-DIMER | March 10, 2005 |
| K042723 | biosite incorporated | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | December 7, 2004 |
| K033491 | roche diagnostics | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER | September 1, 2004 |