510(k) Report

Devices descending from K103824

3 later devices reach Human Iga Liquid Reagent Kit for Use on Spa Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd.20190—
+1K191985Optilite IgA KitThe Binding Site Group, Ltd.20191—
+2K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd.202501