510(k) Report

Devices descending from K964375

9 later devices reach Sysmex SE/Ram-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992875Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp.199971
+1K981950Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500Sysmex Corp.19980—
+2K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd.20160—
+2K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+2K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc.200617
+2K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+2K021241Sysmex XT-Series, Model XT-2000I and XT-1800ISysmex Corporation of America20020—
+3K151133Pentra XLRHoriba Abx Sas20150—
+3K081930Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc.2008029