510(k) K091455

DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL by Diazyme Laboratories — Product Code MZV

K091455 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL". The FDA issued a decision of Substantially Equivalent on August 14, 2009. The device falls under product code MZV (Test, System, Potassium, Enzymatic Method), a Class II device regulated under 21 CFR 862.1600. Diazyme Laboratories has at least 10 other 510(k) clearances on record.