510(k) Report

Devices descending from K844423

4 later devices reach Coat-a-Count Free Testosterone Kit & Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030730Free Testosterone Enzymeimmunoassay (Eia) KitDiagnostics Biochem Canada, Inc.20032—
+1K022533Fastpack Testosterone CalibratorQualigen, Inc.20020—
+2K181017Free Testosterone AccuBind ELISA Test SystemMonobind, Inc.20181—
+3K240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited20240—