510(k) Report

Devices descending from K954045

4 later devices reach Axsym Rubella Igg Antibody Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080766Vidas Rub IggbioMerieux, Inc.20082—
+1K063143Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and CalibratorsOrtho-Clinical Diagnostics, Inc.20060—
+2K243168Alinity i Rubella IgGAbbott Laboratories20250—
+2K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux201504