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) → GHH — Fibrin Split Products # GHH · Fibrin Split Products _Hematology · 21 CFR 864.7320 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH ## Overview - **Product Code:** GHH - **Device Name:** Fibrin Split Products - **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 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K112120](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K112120.md) | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | Diazyme Laboratories | Jan 24, 2013 | SESE | | [K072288](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K072288.md) | PATHFAST D-DIMER | Mitsubishi Kagaku Iatron | May 6, 2009 | SESE | | [K070453](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K070453.md) | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL | Olympus Life & Material Science Europa GmbH (Irish | Jun 11, 2007 | SESE | | [K062203](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K062203.md) | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | Mar 14, 2007 | SESE | | [K042890](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K042890.md) | TRIAGE D-DIMER TEST, MODEL 98100 | Biosite Incorporated | Nov 29, 2004 | SESE | | [K030740](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K030740.md) | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | Apr 1, 2003 | SESE | | [K021877](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K021877.md) | MDA D-DIMER | bioMerieux, Inc. | Aug 7, 2002 | SESE | | [K011143](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K011143.md) | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | May 29, 2001 | SESE | | [K993276](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K993276.md) | SIMPLIFY D-DIMER, MODEL DCGK1 | Agen Biomedical , Ltd. | Dec 14, 1999 | SESE | | [K972316](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K972316.md) | OPUS D-DIMER | Behring Diagnostics, Inc. | Sep 9, 1997 | SESE | | [K945642](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K945642.md) | AGEN DIMERTEST GOLD EIA | Agen Biomedical , Ltd. | Oct 25, 1995 | SESE | | [K921989](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K921989.md) | FDP - SLIDEX DIRECT | Biomerieux Vitek, Inc. | Nov 3, 1993 | SESE | | [K920668](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K920668.md) | MINUTEX D-DIMER LATEX TEST | Biopool AB | Oct 16, 1992 | SESE | | [K905643](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K905643.md) | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | Agen Biomedical , Ltd. | Apr 12, 1991 | SESE | | [K893961](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K893961.md) | ABBOTT IMX(TM) D-DIMER | Abbott Laboratories | Aug 3, 1989 | SESE | | [K890422](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K890422.md) | ABBOTT TESTPACK(TM) D-DIMER | Abbott Laboratories | Mar 27, 1989 | SESE | | [K890399](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K890399.md) | MODIFIED D-DI-TEST KIT | American Bioproducts Co. | Feb 7, 1989 | SESE | | [K880077](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K880077.md) | FIBRINOSTICON | Organon Teknika Corp. | Feb 9, 1988 | SESE | | [K872360](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K872360.md) | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | American Dade | Jul 6, 1987 | SESE | | [K861973](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH/K861973.md) | D-DI TEST KIT | American Bioproducts Co. | Sep 4, 1986 | SESE | ## Top Applicants - Agen Biomedical , Ltd. — 3 clearances - American Bioproducts Co. — 3 clearances - Roche Diagnostics Corp. — 3 clearances - Abbott Laboratories — 2 clearances - E.I. Dupont DE Nemours & Co., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GHH) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com