510(k) Report

Devices descending from K953598

3 later devices reach Series 9100 Plus Automated Differential Hematology Analyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222
+2K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+3K151133Pentra XLRHoriba Abx Sas20150—