GHH · Fibrin Split Products
Hematology · 21 CFR 864.7320 · Class 2
Overview
| Product Code | GHH |
|---|---|
| Device Name | Fibrin Split Products |
| Regulation | 21 CFR 864.7320 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 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 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | Diazyme Laboratories | Jan 24, 2013 | SESE |
| K072288 | PATHFAST D-DIMER | Mitsubishi Kagaku Iatron | May 6, 2009 | SESE |
| K070453 | 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 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | Mar 14, 2007 | SESE |
| K042890 | TRIAGE D-DIMER TEST, MODEL 98100 | Biosite Incorporated | Nov 29, 2004 | SESE |
| K030740 | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | Apr 1, 2003 | SESE |
| K021877 | MDA D-DIMER | bioMerieux, Inc. | Aug 7, 2002 | SESE |
| K011143 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | May 29, 2001 | SESE |
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | Agen Biomedical , Ltd. | Dec 14, 1999 | SESE |
| K972316 | OPUS D-DIMER | Behring Diagnostics, Inc. | Sep 9, 1997 | SESE |
| K945642 | AGEN DIMERTEST GOLD EIA | Agen Biomedical , Ltd. | Oct 25, 1995 | SESE |
| K921989 | FDP - SLIDEX DIRECT | Biomerieux Vitek, Inc. | Nov 3, 1993 | SESE |
| K920668 | MINUTEX D-DIMER LATEX TEST | Biopool AB | Oct 16, 1992 | SESE |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | Agen Biomedical , Ltd. | Apr 12, 1991 | SESE |
| K893961 | ABBOTT IMX(TM) D-DIMER | Abbott Laboratories | Aug 3, 1989 | SESE |
| K890422 | ABBOTT TESTPACK(TM) D-DIMER | Abbott Laboratories | Mar 27, 1989 | SESE |
| K890399 | MODIFIED D-DI-TEST KIT | American Bioproducts Co. | Feb 7, 1989 | SESE |
| K880077 | FIBRINOSTICON | Organon Teknika Corp. | Feb 9, 1988 | SESE |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | American Dade | Jul 6, 1987 | SESE |
| K861973 | 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
