510(k) Report

Devices descending from K852992

3 later devices reach Para Check (Aka Eight Check-C) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143577XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc.20152—
+2K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc.20171—
+3K210346Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc.20220—