GFK
- Product code
- GFK
- Device name
- Fibrinogen Determination Standards And Controls
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.7340
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
Official FDA classification page: GFK
Classification and pathway per current FDA publications. Data from openFDA (CC0).