510(k) K063647

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH by Thermo Electron OY — Product Code NDY

K063647 is an FDA 510(k) premarket notification submitted by Thermo Electron OY for the device "CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH". The FDA issued a decision of Substantially Equivalent on March 12, 2007. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Thermo Electron OY has at least 9 other 510(k) clearances on record.