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510(k) K093861

Device
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
Applicant
IRIS INTERNATIONAL, INC.
510(k) number
K093861
Product code
LKM  
Decision
Substantially Equivalent (SESE)
Decision date
2010-02-05
Date received
2009-12-16
Regulation
864.5200
Classification name
Counter, Urine Particle
Medical specialty
Hematology
Review panel
Pathology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELLEN JOHNSTON
Address
9172 Eton Ave. Chatsworth CA US 91311 91311

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
K252580iQ200 SeriesBeckman Coulter, Inc.2025-09-10
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
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

Legacy Summary#

summary

FDA Review#

Decision Summary