510(k) Report

Devices descending from K962988

6 later devices reach Coulter Gen-S System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041882Flowcare SystemPointcare Technologies, Inc.20041—
+1K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222
+1K993356Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp.20000—
+2K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+2K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+3K151133Pentra XLRHoriba Abx Sas20150—