510(k) Report

Devices descending from K143577

2 later devices reach XW-100 Automated Hematology Analyzer, XW QC CHECK through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc.20171—
+2K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc.20220—