510(k) K240273

Access Free T4 by Beckman Coulter, Inc. — Product Code CEC

K240273 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Free T4". The FDA issued a decision of Substantially Equivalent on March 6, 2024. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.