510(k) Report

Devices descending from K823355

11 later devices reach Coulter-Counter #S Plus IV & Lyse S +D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990352Coulter AC T Diff 2 AnalyzerCoulter Corp.199931
+1K973634Coulter AC.T Diff AnalyzerCoulter Corp.19974—
+1K964988Coulter AC.T Series AnalyzerCoulter Corp.19976—
+1K955715Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)Abbott Laboratories199631
+2K093394BC-3200 Auto Hematology Analyzer,M-30D Diluent, M-30R Rinse, M-30CFL Lyse, M-30E-Z…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20101—
+2K063407BC-3200 Auto Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.20070—
+2K972354Abbott Cell-Dyn 3200 SystemAbbott Laboratories199726
+2K971469Coulter Act Tron Cell ControlCoulter Corp.19970—
+3K143348BC-3600 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd.20150—
+3K061667Cell-Dyn Ruby SystemAbbott Laboratories2006012
+3K980614Abbott Cell-Dyn 3000 Series Hematology SystemsAbbott Laboratories199815