510(k) Report

Devices descending from K983510

13 later devices reach Chemstrip 101 Urine Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033548Roche Diagnostics Urisys 1100 Urine AnalyzerRoche Diagnostics Corp.200301
+1K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems20032—
+1K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems200211—
+2K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.20230—
+2K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc.20160—
+2K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I2011311
+2K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc.20094—
+2K060280Ichem 100 Urine Chemistry AnalyzerIris International, Inc.200601
+3K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd.20240—
+3K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.202116
+3K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.20172—
+3K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…Arkray, Inc.201301
+4K252580iQ200 SeriesBeckman Coulter, Inc.202502