FDA Product Code LKM: Counter, Urine Particle
FDA product code LKM covers urine particle counters used in clinical urinalysis.
These automated analyzers use flow cytometry or digital imaging to identify and count formed elements in urine — including red blood cells, white blood cells, casts, bacteria, and epithelial cells — replacing manual microscopy in high-volume laboratories with faster, more reproducible results.
LKM devices are Class II medical devices, regulated under 21 CFR 864.5200 and reviewed by the FDA Hematology panel.
Leading manufacturers include Beckman Coulter, Inc., Sysmex America, Inc. and Roche Diagnostics.
List of Counter, Urine Particle devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Counter, Urine Particle devices (product code LKM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Hematology FDA review panel. Browse all Hematology devices →