510(k) K222610

Elecsys Anti-Tg by Roche Diagnostics — Product Code JZO

K222610 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Anti-Tg". The FDA issued a decision of Substantially Equivalent on September 15, 2023. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Roche Diagnostics has at least 10 other 510(k) clearances on record.