510(k) Report

Devices descending from K080887

3 later devices reach Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131444UA-Cellular CompleteStreck20141—
+1K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…Arkray, Inc.201301
+2K170091UA-Cellular CompleteStreck20170—