510(k) K080662

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR by Genzyme Corporation — Product Code NDY

K080662 is an FDA 510(k) premarket notification submitted by Genzyme Corporation for the device "GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR". The FDA issued a decision of Substantially Equivalent on May 15, 2008. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Genzyme Corporation has at least 5 other 510(k) clearances on record.