510(k) Report

Devices descending from K922832

5 later devices reach Quanta Lite SS-B Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141210Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B ControlsInova Diagnostics, Inc.20152—
+1K123261Euroimmun Anti-NRNP/SM Elisa (Igg)Euroimmun US20131—
+2K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited20260—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+2K140224Euroimmun Euroline Ena Profile 9AG (Igg)Euroimmun US20140—