LKM

Counter, Urine Particle

Product code

LKM

Device name

Counter, Urine Particle

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 (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

15 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-10.

2 summaries are archived here for direct download.