510(k) K070708

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 by Olympus Life & Material Science Europa GmbH (Irish — Product Code CEC

K070708 is an FDA 510(k) premarket notification submitted by Olympus Life & Material Science Europa GmbH (Irish for the device "OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104". The FDA issued a decision of Substantially Equivalent on August 21, 2007. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Olympus Life & Material Science Europa GmbH (Irish has at least 2 other 510(k) clearances on record.