510(k) K031269

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS by Beckman Coulter, Inc. — Product Code MSW

K031269 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS". The FDA issued a decision of Substantially Equivalent on May 2, 2003. The device falls under product code MSW (System, Test, Thyroglobulin), a Class II device regulated under 21 CFR 866.6010. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.