510(k) Report

Devices descending from K961510

5 later devices reach Acs FRT4 Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083373Immulite 2000 Free T4Siemens Healthcare Diagnostics, Inc.20091—
+1K080167Acs 180 and Advia Centaur FT4 ImmunoassaysSiemens Healthcare Diagnostics20082—
+2K182423Maglumi 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.20180—
+2K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc.20160—
+2K132249Advia Centaur FT4, Advia Centaur T4Siemens Healthcare Diagnostics, Inc.20130—