GHHClass II
Fibrin Split Products
21 CFR 864.7320 / Hematology
GHH is the FDA product code for Fibrin Split Products, a class II device type, regulated under 21 CFR 864.7320. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- GHH
- Device name
- Fibrin Split Products
- Regulation
- 21 CFR 864.7320
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 28
- Ingested recalls
- 9
Clearances, product code GHH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1985 | 5 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2013 | 1 |
Applicants with the most clearances
Product code GHH| Applicant | Clearances |
|---|---|
| Agen Biomedical, Ltd. | 3 |
| American Bioproducts Co. | 3 |
| Roche Diagnostics GmbH | 3 |
| Abbott Medical | 2 |
| E.I. Dupont de Nemours & Co., Inc. | 2 |
| bioMerieux, Inc. | 2 |
| American Dade | 1 |
| American Hospital Supply | 1 |
| Behring Diagnostics, Inc. | 1 |
| Biomerieux Vitek, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.