510(k) Report

Devices descending from K030730

2 later devices reach Free Testosterone Enzymeimmunoassay (Eia) Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181017Free Testosterone AccuBind ELISA Test SystemMonobind, Inc.20181—
+2K240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited20240—