510(k) K063086

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS by Thermo Electron OY — Product Code DDG

K063086 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS". The FDA issued a decision of Substantially Equivalent on August 8, 2007. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Thermo Electron OY has at least 9 other 510(k) clearances on record.