510(k) Report

Devices descending from K912494

13 later devices reach Sysmex (TM) R-3000 Automated Reticulocyte Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990311Vega Retic Automated Hematology AnalyzerAbx Diagnostics19994—
+1K981950Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500Sysmex Corp.19980—
+1K964375Sysmex SE/Ram-1Sysmex Corp.19979—
+2K151133Pentra XLRHoriba Abx Sas20150—
+2K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+2K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222
+2K992875Sysmex XE-2100, Automatated Hematology AnalyzerSysmex Corp.199971
+2K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics19993—
+3K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd.20160—
+3K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+3K061616Coulter LH 780 Hematology AnalyzerBeckman Coulter, Inc.200617
+3K021241Sysmex XT-Series, Model XT-2000I and XT-1800ISysmex Corporation of America20020—
+4K081930Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc.2008029