Product code LKM— Hematology
939UDX URINE PATHOLOGY SYSTEM
- Classification name
- Counter, Urine Particle
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code LKM
FDA has cleared devices under product code LKM between 1982 and 2025, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2021
- 2020
- 2018
- 2010
- 2009
- 2008
- 2007
- 2006
- 2002
- 2001
- 2000
- 1996
- 1982
Top applicants under product code LKM
Recent clearances under product code LKM
- K252580 — iQ200 Series
- K232416 — AUTION EYE AI-4510 Urine Particle Analysis System
- K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- K200811 — cobas u 701 microscopy analyzer
- K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer
- K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
- K083002 — SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
- K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
- K070910 — SYSMEX MODEL UF1000I
- K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
- K022774 — IQ 200 SYSTEM
- K012372 — SYSMEX UF-50
- K000373 — 939UDX URINE PATHOLOGY SYSTEM
- K961054 — SYSMEX UF-100
- K822823 — HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
Data sourced from openFDA. This site is unofficial and independent of the FDA.