510(k) Report

Devices descending from K080167

2 later devices reach Acs 180 and Advia Centaur FT4 Immunoassays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182423Maglumi 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.20180—
+1K132249Advia Centaur FT4, Advia Centaur T4Siemens Healthcare Diagnostics, Inc.20130—