510(k) K062581

OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM by Olympus America, Inc. — Product Code JLW

K062581 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 2006. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Olympus America, Inc. has at least 10 other 510(k) clearances on record.