510(k) Report

Devices descending from K951496

8 later devices reach Cell-Dyn 3500 Multi-Parameter Automated Hematology Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961439Abbott Cell-Dyn 4000 SystemAbbott Diagnostics199677
+2K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+2K032524Advia 60 Hematology AnalyzerBayer Healthcare, LLC20030—
+2K024002Pentra 80Abx Diagnostics200312
+2K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222
+2K012934Cell-Dyn 3200 System with Absolute and Percent ReticulocyteAbbott Laboratories20011—
+3K151133Pentra XLRHoriba Abx Sas20150—
+3K061667Cell-Dyn Ruby SystemAbbott Laboratories2006012