510(k) Report

Devices descending from K971736

5 later devices reach Sysmex Immature Reticulocyte Fraction (Irf) Parameter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993356Coulter Hematology Analyzers with Irf & MRV AnalysesCoulter Corp.20000—
+1K991839Abx Pentra 120 Retic Automated Hematology AnalyzerAbx Diagnostics19993—
+2K151133Pentra XLRHoriba Abx Sas20150—
+2K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+2K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222