510(k) Report

Devices descending from K992875

7 later devices reach Sysmex XE-2100, Automatated Hematology Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd.20160—
+1K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+1K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc.200617
+1K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+1K021241Sysmex XT-Series, Model XT-2000I and XT-1800ISysmex Corporation of America20020—
+2K151133Pentra XLRHoriba Abx Sas20150—
+2K081930Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc.2008029