510(k) K063209

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL by Thermo Electron OY — Product Code LCP

K063209 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL". The FDA issued a decision of Substantially Equivalent on March 21, 2007. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Thermo Electron OY has at least 9 other 510(k) clearances on record.