510(k) Report

Devices descending from K091867

3 later devices reach Advia Centaur SHBG Readypack, Low and High Calibrators and Master Curve… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+2K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+2K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—