510(k) Report

Devices descending from K052000

2 later devices reach Architect CA 19-9XR Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.20191—
+2K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.20200—