510(k) Report

Devices descending from K010668

6 later devices reach Bayer Diagnostics Advia Centaur Rubella Igm Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122397Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc.20123—
+1K092587Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemBio-Rad Laboratories20101—
+2K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…Bio-Rad Laboratories20170—
+2K132234Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc.20132—
+3K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc.20161—
+4K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.20180—