510(k) K171072

N Latex Cystatin C; N Protein Standard UY by Siemens Healthcare Diagnostics Products GmbH — Product Code NDY

K171072 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products GmbH for the device "N Latex Cystatin C; N Protein Standard UY". The FDA issued a decision of Substantially Equivalent on May 12, 2017. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Siemens Healthcare Diagnostics Products GmbH has at least 10 other 510(k) clearances on record.