510(k) K071388

GENTIAN CYSTATIN C IMMUNOASSAY by Gentian AS — Product Code NDY

K071388 is an FDA 510(k) premarket notification submitted by Gentian AS for the device "GENTIAN CYSTATIN C IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on November 6, 2007. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Gentian AS has at least 1 other 510(k) clearance on record.