510(k) Report

Devices descending from K192063

1 later device reach PGDx elio tissue complete through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.20250—