510(k) K072270

DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) by Diazyme Laboratories — Product Code NDY

K072270 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)". The FDA issued a decision of Substantially Equivalent on February 1, 2008. 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.