GKB
- Product code
- GKB
- Device name
- Device, Automated Sedimentation Rate
- Device class
- Class 1
- 21 CFR
- 21 CFR 864.5800
- Medical specialty
- Hematology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
Official FDA classification page: GKB
Classification and pathway per current FDA publications. Data from openFDA (CC0).