510(k) K050202

CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS by Beckman Coulter, Inc. — Product Code CGR

K050202 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 9, 2005. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.