510(k) K242190

Access Cortisol; DxC 500i Clinical Analyzer by Beckman Coulter, Inc. — Product Code CGR

K242190 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Cortisol; DxC 500i Clinical Analyzer". The FDA issued a decision of Substantially Equivalent on March 5, 2025. 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.