510(k) K131244

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET by Roche Diagnostics — Product Code CEC

K131244 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET". The FDA issued a decision of Substantially Equivalent on January 27, 2014. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Roche Diagnostics has at least 10 other 510(k) clearances on record.