510(k) Report

Devices descending from K880736

4 later devices reach Nova Lite (TM) Ana through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150155NOVA Lite DAPI ANA KitInova Diagnostics, Inc.20150—
+1K072149Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01Phadia US, Inc.20082—
+2K190710EliA SymphonyS ImmunoassayPhadia AB20191—
+3K253367EliA CTD 13 ScreenPhadia AB20260—