510(k) K982250

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER by Beckman Instruments, Inc. — Product Code CEC

K982250 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER". The FDA issued a decision of Substantially Equivalent on July 14, 1998. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.