510(k) Report

Devices descending from DEN180032

3 later devices reach Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230917FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc.20231—
+1K212204Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin…Cd Diagnostics, Inc.20210—
+2K260787FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc.20260—