510(k) Report

Devices descending from K013783

11 later devices reach Aution Max AX-4280 Urinalysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.20230—
+1K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I2011311
+1K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc.20094—
+1K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems20032—
+2K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd.20240—
+2K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.202116
+2K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.20172—
+2K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc.20160—
+2K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…Arkray, Inc.201301
+2K060280Ichem 100 Urine Chemistry AnalyzerIris International, Inc.200601
+3K252580iQ200 SeriesBeckman Coulter, Inc.202502