GKE
- Product code
- GKE
- Device name
- Osmotic Fragility Testing
- Device class
- Class 1
- 21 CFR
- 21 CFR 864.6600
- Medical specialty
- Hematology
- Marketing pathway
- 510(K) Exempt
Official FDA classification page: GKE
Classification and pathway per current FDA publications. Data from openFDA (CC0).