Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7320](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7320) → DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control # DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control _Hematology · 21 CFR 864.7320 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP ## Overview - **Product Code:** DAP - **Device Name:** Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - **Regulation:** [21 CFR 864.7320](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7320) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K172903.md) | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | Nov 22, 2017 | SESE | | [K162227](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K162227.md) | STA® - Liatest® D-Di | Diagnostica Stago | Dec 10, 2016 | SESE | | [K160885](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K160885.md) | HemosIL D-Dimer HS | Instrumentation Laboratory CO | Oct 27, 2016 | SESE | | [K151534](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K151534.md) | HemosIL D-Dimer HS | Instrumentation Laboratory CO | Jul 6, 2015 | SESE | | [K141144](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K141144.md) | STA LIATEST D-DI | Diagnostica Stago | Sep 3, 2014 | SESE | | [K112818](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K112818.md) | VIDAS D-DIMER EXCLUSION II (DEX2) | bioMerieux, Inc. | Jul 31, 2012 | SESE | | [K110303](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K110303.md) | STRATUS CS ACUTE CARE D-DIMER | Siemens Healthcare Diagnostics | May 16, 2011 | SESE | | [K093626](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K093626.md) | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | Nov 29, 2010 | SESE | | [K090264](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K090264.md) | HEMOSIL D-DIMER HS 500, CONTROLS | Instrumentation Laboratory CO | Feb 5, 2010 | SESE | | [K091916](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K091916.md) | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | Oct 29, 2009 | SESE | | [K081732](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K081732.md) | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | Siemens Healthcare Diagnostics | Oct 24, 2008 | SESE | | [K073042](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K073042.md) | HEMOSIL D-DIMER | Instrumentation Laboratory | Jul 31, 2008 | SESE | | [K080069](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K080069.md) | DIMERTEST | American Diagnostica, Inc. | Feb 13, 2008 | SESE | | [K070927](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K070927.md) | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | Sep 17, 2007 | SESE | | [K063356](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K063356.md) | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | Dade Behring, Inc. | Mar 23, 2007 | SESE | | [K051597](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K051597.md) | STRATUS CS D-DIMER | Dade Behring, Inc. | Aug 17, 2005 | SESE | | [K050544](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K050544.md) | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | Apr 26, 2005 | SESE | | [K050278](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K050278.md) | HEMOSIL D-DIMER | Instrumentation Laboratory CO | Mar 10, 2005 | SESE | | [K042723](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K042723.md) | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | Biosite Incorporated | Dec 7, 2004 | SESE | | [K033491](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K033491.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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