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LKM — Counter, Urine Particle Class II

FDA Device Classification

Classification Details

Product Code
LKM
Device Class
Class II
Regulation Number
864.5200
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252580beckman coulteriQ200 SeriesSeptember 10, 2025
K232416arkrayAUTION EYE AI-4510 Urine Particle Analysis SystemMay 3, 2024
K210127beckman coulteriQ200 System, iChemVELOCITY Automated Urine Chemistry SystemJuly 2, 2021
K200811roche diagnosticscobas u 701 microscopy analyzerNovember 6, 2020
K171883sysmex americaSysmex UF-5000 Fully Automated Urine Particle AnalyzerApril 23, 2018
K093861iris internationalIQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEFebruary 5, 2010
K083002sysmex americaSYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZERFebruary 3, 2009
K080887sysmex americaSYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWAREMay 2, 2008
K070910sysmex americaSYSMEX MODEL UF1000IMay 25, 2007
K053135sysmex americaSYSMEX UF-100I AUTOMATED URINE CELL ANALYZERJanuary 4, 2006
K022774intl. remote imaging systemsIQ 200 SYSTEMOctober 21, 2002
K012372sysmexSYSMEX UF-50September 28, 2001
K000373intl. remote imaging systems939UDX URINE PATHOLOGY SYSTEMApril 14, 2000
K961054sysmexSYSMEX UF-100October 28, 1996
K822823eko scannHEMATOLOGY COMPUTER-INTERFACE, VISCOUNTOctober 18, 1982