510(k) Report

Devices descending from K960054

4 later devices reach 900UDX Urine Pathology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I2011311
+2K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.202116
+2K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.20172—
+3K252580iQ200 SeriesBeckman Coulter, Inc.202502