510(k) Report

Devices descending from K061165

1 later device reach Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB20160—