510(k) K052082

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 by Beckman Coulter, Inc. — Product Code JMG

K052082 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020". The FDA issued a decision of Substantially Equivalent on August 19, 2005. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.