510(k) Report

Devices descending from K063565

4 later devices reach Quanta Lite SS-a 52 Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141655Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsInova Diagnostics, Inc.20152—
+1K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US20140—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+2K210902EliA Ro52, EliA Ro60Phadia AB20220—