510(k) Report

Devices descending from DEN090004

5 later devices reach OVA1 Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150588OVA1 Next GenerationVermillion, Inc.20160—
+1K103358Roma (HE4 Eia + Architect CA 125 II)Fujirebio Diagnostics,Inc.20113—
+2K153607ROMA Calculation Tool Using Elecsys AssaysRoche Diagnostics20160—
+2K160090Lumipulse G ROMAFujirebio Diagnostics,Inc.20160—
+2K151502Architect RomaFujirebio Diagnostics,Inc.20160—