510(k) Report

Devices descending from K093098

4 later devices reach Aution Max Model AX-4030 Urinalysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd.20240—
+1K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.20230—
+1K160062AUTION ELEVEN Semi-Automated Urinalysis SystemArkray, Inc.20160—
+1K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…Arkray, Inc.201301