510(k) Report

Devices descending from K191635

1 later device reach Optilite IgM Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd.202501