510(k) Report

Devices descending from K082129

3 later devices reach Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191635Optilite IgM KitThe Binding Site Group, Ltd.201911
+1K191465Human IgM Kit for use on SPAPlusThe Binding Site Group, Ltd.201901
+2K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd.202501