510(k) K111664

DIAZYME CYSTATIN C POC TEST KIT by Diazyme Laboratories — Product Code NDY

K111664 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME CYSTATIN C POC TEST KIT". The FDA issued a decision of Substantially Equivalent on March 30, 2012. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Diazyme Laboratories has at least 10 other 510(k) clearances on record.