510(k) K063705

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL by Thermo Electron OY — Product Code NDW

K063705 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL". The FDA issued a decision of Substantially Equivalent on October 9, 2007. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Thermo Electron OY has at least 9 other 510(k) clearances on record.