510(k) Report

Devices descending from K962719

4 later devices reach Hycor HY.Tec/Manual SS-a Auto-Antibody through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141328Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsInova Diagnostics, Inc.20153—
+2K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited20260—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+2K210902EliA Ro52, EliA Ro60Phadia AB20220—