510(k) Report

Devices descending from K062583

1 later device reach Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…Phadia AB20190—