510(k) Report

Devices descending from K041173

3 later devices reach Celikey Igg Itg Igg Antibodies, Model 17996 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062583Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01Phadia US, Inc.20061—
+1K053383Fidis CeliacBiomedical Diagnostics (Bmd) SA20060—
+2K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…Phadia AB20190—