510(k) Report

Devices descending from K970146

4 later devices reach Elecsys Calcheck Testosterone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc.20143—
+2K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+3K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+3K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—