GFX — Fibrinogen Standard Class II
FDA Device Classification
Classification Details
- Product Code
- GFX
- Device Class
- Class II
- Regulation Number
- 864.7340
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K072304 | dade behring | FIBRINOGEN CALIBRATOR KIT | September 19, 2007 |
| K994341 | dade behring | FIBRINOGEN CALIBRATOR KIT | March 3, 2000 |
| K812628 | e.i. dupont de nemours and co | ACA FIBRINOGEN CALIBRATOR | November 24, 1981 |