510(k) Report

Devices descending from K813401

3 later devices reach Coat-a-Count Testosterone Ria Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021326Vidas Testosterone (Tes), Model 30 418bioMerieux, Inc.200211
+1K983507Vitros Immunodiagnostic Products Testosterone AssayOrtho-Clinical Diagnostics, Inc.19980—
+2K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504