510(k) K082763

DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B by Diazyme Laboratories — Product Code MZU

K082763 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B". The FDA issued a decision of Substantially Equivalent on November 12, 2008. The device falls under product code MZU (System, Test, Sodium, Enzymatic Method), a Class II device regulated under 21 CFR 862.1665. Diazyme Laboratories has at least 10 other 510(k) clearances on record.