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Panels › Hematology › Product code LKM · Class 2

Counter, Urine Particle

Regulation 864.5200

0510(k)s in 12 months (15 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in LKM

Company510(k)sRecalls
Beckman Coulter, Inc.25
Sysmex America, Inc.51
Intl. Remote Imaging Systems20
Sysmex Corp.20
Arkray, Inc.10
Eko Scann AB10
Iris International, Inc.10
Roche Diagnostics10
Decided510(k)Device and applicantCode
Sep 10, 2025K252580iQ200 Series
Beckman Coulter, Inc.
LKM
May 3, 2024K232416AUTION EYE AI-4510 Urine Particle Analysis System
Arkray, Inc., JP
LKM
Jul 2, 2021K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry System
Beckman Coulter, Inc.
LKM
Nov 6, 2020K200811cobas u 701 microscopy analyzer
Roche Diagnostics
LKM
Apr 23, 2018K171883Sysmex UF-5000 Fully Automated Urine Particle Analyzer
Sysmex America, Inc.
LKM
Feb 5, 2010K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
Iris International, Inc.
LKM
Feb 3, 2009K083002SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
Sysmex America, Inc.
LKM
May 2, 2008K080887SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
Sysmex America, Inc.
LKM
May 25, 2007K070910SYSMEX MODEL UF1000I
Sysmex America, Inc.
LKM
Jan 4, 2006K053135SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
Sysmex America, Inc.
LKM
Oct 21, 2002K022774IQ 200 SYSTEM
Intl. Remote Imaging Systems
LKM
Sep 28, 2001K012372SYSMEX UF-50
Sysmex Corp.
LKM
Apr 14, 2000K000373939UDX URINE PATHOLOGY SYSTEM
Intl. Remote Imaging Systems
LKM
Oct 28, 1996K961054SYSMEX UF-100
Sysmex Corp.
LKM
Oct 18, 1982K822823HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT
Eko Scann AB
LKM

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