510(k) Report

Devices descending from K091313

3 later devices reach Sysmex Model XT-4000I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091539IQ 200 Urine Analizer Body Fluids ModuleIris Diagnostics20102—
+2K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.202116
+3K252580iQ200 SeriesBeckman Coulter, Inc.202502