510(k) K063131

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS by Thermo Electron OY — Product Code KLT

K063131 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS". The FDA issued a decision of Substantially Equivalent on October 5, 2007. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Thermo Electron OY has at least 9 other 510(k) clearances on record.