510(k) K151799

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 by Phadia AB — Product Code JZO

K151799 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000". The FDA issued a decision of Substantially Equivalent on March 25, 2016. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Phadia AB has at least 10 other 510(k) clearances on record.