510(k) Report

Devices descending from K934562

3 later devices reach Ciba Corning Acs Testosterone Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133491Advia Centaur Testosterone (Tsto)Siemens Healthcare Diagnostics, Inc.20140—
+1K021326Vidas Testosterone (Tes), Model 30 418bioMerieux, Inc.200211
+2K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504