510(k) Report

Devices descending from K141655

2 later devices reach Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+1K210902EliA Ro52, EliA Ro60Phadia AB20220—