510(k) K030124

OLYMPUS FERRITIN REAGENT by Olympus America, Inc. — Product Code DBF

K030124 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS FERRITIN REAGENT". The FDA issued a decision of Substantially Equivalent on February 6, 2003. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Olympus America, Inc. has at least 10 other 510(k) clearances on record.