510(k) Report

Devices descending from K103358

3 later devices reach Roma (HE4 Eia + Architect CA 125 II) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153607ROMA Calculation Tool Using Elecsys AssaysRoche Diagnostics20160—
+1K160090Lumipulse G ROMAFujirebio Diagnostics,Inc.20160—
+1K151502Architect RomaFujirebio Diagnostics,Inc.20160—