510(k) Report

Devices descending from K932030

8 later devices reach Coulter STKS with Reticulocyte Analysis Capability through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962988Coulter Gen-S SystemCoulter Corp.199664
+1K961278Coulter STKS Analyzer with CD4 & CD8 Lymphocyte AnalysisCoulter Corp.19960—
+2K041882Flowcare SystemPointcare Technologies, Inc.20041—
+2K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222
+2K993356Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp.20000—
+3K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+3K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+4K151133Pentra XLRHoriba Abx Sas20150—