510(k) K083906

ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 by Siemens Healthcare Diagnostics — Product Code NDY

K083906 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487". The FDA issued a decision of Substantially Equivalent on March 11, 2009. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.