DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Hematology · 21 CFR 864.7320 · Class 2
Overview
| Product Code | DAP |
|---|---|
| Device Name | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | Nov 22, 2017 | SESE |
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | Dec 10, 2016 | SESE |
| K160885 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | Oct 27, 2016 | SESE |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | Jul 6, 2015 | SESE |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | Sep 3, 2014 | SESE |
| K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | bioMerieux, Inc. | Jul 31, 2012 | SESE |
| K110303 | STRATUS CS ACUTE CARE D-DIMER | Siemens Healthcare Diagnostics | May 16, 2011 | SESE |
| K093626 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | Nov 29, 2010 | SESE |
| K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | Instrumentation Laboratory CO | Feb 5, 2010 | SESE |
| K091916 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | Oct 29, 2009 | SESE |
| K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | Siemens Healthcare Diagnostics | Oct 24, 2008 | SESE |
| K073042 | HEMOSIL D-DIMER | Instrumentation Laboratory | Jul 31, 2008 | SESE |
| K080069 | DIMERTEST | American Diagnostica, Inc. | Feb 13, 2008 | SESE |
| K070927 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | Sep 17, 2007 | SESE |
| K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | Dade Behring, Inc. | Mar 23, 2007 | SESE |
| K051597 | STRATUS CS D-DIMER | Dade Behring, Inc. | Aug 17, 2005 | SESE |
| K050544 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | Apr 26, 2005 | SESE |
| K050278 | HEMOSIL D-DIMER | Instrumentation Laboratory CO | Mar 10, 2005 | SESE |
| K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | Biosite Incorporated | Dec 7, 2004 | SESE |
| K033491 | ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS | Roche Diagnostics Corp. | Sep 1, 2004 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 9 clearances
- Dade Behring, Inc. — 6 clearances
- Organon Teknika Corp. — 5 clearances
- American Bioproducts Co. — 4 clearances
- Siemens Healthcare Diagnostics — 4 clearances
