510(k) Report

Devices descending from K040435

4 later devices reach Roche Diagnostics Tina-Quant Iga Gen.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site20123—
+2K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd.20190—
+2K191985Optilite IgA KitThe Binding Site Group, Ltd.20191—
+3K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd.202501