510(k) Report

Devices descending from K961439

7 later devices reach Abbott Cell-Dyn 4000 System through their predicates, nearest generation first.

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