510(k) Report

Devices descending from K141328

3 later devices reach Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited20260—
+1K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+1K210902EliA Ro52, EliA Ro60Phadia AB20220—