510(k) Report

Devices descending from K961054

7 later devices reach Sysmex UF-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070910Sysmex Model UF1000ISysmex America, Inc.20076—
+2K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.20180—
+2K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…Arkray, Inc.201301
+2K083002Sysmex UF-500I Automated Urine Particle AnalyzerSysmex America, Inc.20090—
+2K080887Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam SoftwareSysmex America, Inc.200831
+3K131444UA-Cellular CompleteStreck20141—
+4K170091UA-Cellular CompleteStreck20170—