510(k) Report

Devices descending from K221842

2 later devices reach Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics20250—
+1K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics20230—