510(k) K162606

Elecsys TSH assay, cobas e 801 Immunoassay analyzer by Roche Diagnostics — Product Code JLW

K162606 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys TSH assay, cobas e 801 Immunoassay analyzer". The FDA issued a decision of Substantially Equivalent on January 23, 2017. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Roche Diagnostics has at least 10 other 510(k) clearances on record.