FDA Product Code GKZ: Counter, Differential Cell
FDA product code GKZ covers differential cell counters used in hematology laboratories.
These automated or semi-automated instruments classify and count white blood cell subtypes — neutrophils, lymphocytes, monocytes, eosinophils, and basophils — from blood smears or liquid samples. The differential count is a critical component of the complete blood count used to diagnose infections, hematological disorders, and immune conditions.
GKZ devices are Class II medical devices, regulated under 21 CFR 864.5220 and reviewed by the FDA Hematology panel.
Leading manufacturers include Sysmex America, Inc., Abbott Laboratories and Beckman Coulter, Inc..
FDA 510(k) Cleared Counter, Differential Cell Devices (Product Code GKZ)
About Product Code GKZ - Regulatory Context
510(k) Submission Activity
379 total 510(k) submissions under product code GKZ since 1977, with 379 receiving FDA clearance (average review time: 173 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GKZ have taken an average of 221 days to reach a decision - up from 172 days historically. Manufacturers should account for longer review timelines in current project planning.
GKZ devices are reviewed by the Hematology panel. Browse all Hematology devices →