510(k) K193313

Elecsys Anti-TSHR by Roche Diagnostics — Product Code JZO

K193313 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Anti-TSHR". The FDA issued a decision of Substantially Equivalent on February 27, 2020. 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.