510(k) K232904

Access Ostase by Beckman Coulter — Product Code CIN

K232904 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "Access Ostase". The FDA issued a decision of Substantially Equivalent on April 15, 2024. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Beckman Coulter has at least 10 other 510(k) clearances on record.