510(k) K231832

Access Myoglobin by Beckman Coulter, Inc. — Product Code DDR

K231832 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Myoglobin". The FDA issued a decision of Substantially Equivalent on September 18, 2023. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.