510(k) Report

Devices descending from K101852

3 later devices reach Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.202116
+1K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.20172—
+2K252580iQ200 SeriesBeckman Coulter, Inc.202502