AI devices with FDA product code LKM — Counter, Urine Particle

Product code LKM (“Counter, Urine Particle” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Hematology panel (1). The most recent decision was AUTION EYE AI-4510 Urine Particle Analysis System on May 3, 2024.