510(k) Report

Devices descending from K911626

5 later devices reach System 9000, Interpretive Diff Cell Counter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K960072Spirit Hematology System Model LE, CP, & AXBiochem Immunosystems (U.S.), Inc.19970—
+1K953598Series 9100 Plus Automated Differential Hematology AnalyzersSerono Diagnostics, Inc.19963—
+2K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics200222
+3K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx200511
+4K151133Pentra XLRHoriba Abx Sas20150—