510(k) Report

Devices descending from K993585

1 later device reach Varelisa Tpo Antibodies, Model 12348/12396 through their predicates, nearest generation first.

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