510(k) Report

Devices descending from K952130

2 later devices reach Orgentec Anti-TG Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992790Brahms Diagnostica Dynotest Anti-TGBrahms Diagnostica, LLC19991—
+2K012777Acs: 180 and Advia Centaur Anti-Thyroglobulin ImmunoassaysBayer Corp.200104