AI devices with FDA product code GKZ — Counter, Differential Cell
Product code GKZ (“Counter, Differential Cell” in openFDA) covers 5 devices on the FDA AI-enabled list, from 4 companies. Most are reviewed by the Hematology panel (5). The most recent decision was Athelas Home on February 6, 2026.
5AI devices
3Companies
2013First decision
2026-02-06Latest decision
Trend: devices per year
20132018201920222026