GKR
- Product code
- GKR
- Device name
- System, Hemoglobin, Automated
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5620
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 39 (all years; only the last 3 years are listed here)
Official FDA classification page: GKR
Classification and pathway per current FDA publications. Data from openFDA (CC0).