FDA.reportPublic FDA data

510(k) K252580

Device
iQ200 Series
Applicant
Beckman Coulter, Inc.
510(k) number
K252580
Product code
LKM
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-10
Date received
2025-08-15
Regulation
864.5200
Classification name
Counter, Urine Particle
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Shilpa Pillai
Address
11800 SW 147th Ave. Miami FL US 33196 33196

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LKM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc.2024-05-03
K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.2021-07-02
K200811cobas u 701 microscopy analyzerRoche Diagnostics2020-11-06
K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.2018-04-23
K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEIris International, Inc.2010-02-05
K083002SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZERSysmex America, Inc.2009-02-03
K080887SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARESysmex America, Inc.2008-05-02
K070910SYSMEX MODEL UF1000ISysmex America, Inc.2007-05-25
K053135SYSMEX UF-100I AUTOMATED URINE CELL ANALYZERSysmex America, Inc.2006-01-04
K022774IQ 200 SYSTEMIntl. Remote Imaging Systems2002-10-21
K012372SYSMEX UF-50Sysmex Corp.2001-09-28
K000373939UDX URINE PATHOLOGY SYSTEMIntl. Remote Imaging Systems2000-04-14
K961054SYSMEX UF-100Sysmex Corp.1996-10-28
K822823HEMATOLOGY COMPUTER-INTERFACE, VISCOUNTEko Scann AB1982-10-18