GKL
- Product code
- GKL
- Device name
- Counter, Cell, Automated (Particle Counter)
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5200
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (all years, FDA)
- 130 (all years; only the last 3 years are listed here)
Official FDA classification page: GKL
Classification and pathway per current FDA publications. Data from openFDA (CC0).