EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

About This 510(k) Submission

K151799 is an FDA 510(k) clearance for the EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on March 25, 2016, 267 days after receiving the submission on July 2, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.