510(k) Report

Devices descending from K955907

6 later devices reach Boehringer Mannheim Iga Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040435Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp.200441
+1K982382Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc.199801
+2K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site20123—
+3K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd.20190—
+3K191985Optilite IgA KitThe Binding Site Group, Ltd.20191—
+4K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd.202501