510(k) Report

Devices descending from K112624

2 later devices reach Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics20161—
+2K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.20250—