510(k) K042191

DIAZYME POTASSIUM ENZYMATIC ASSAY KIT by Diazyme Laboratories — Product Code MZV

K042191 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME POTASSIUM ENZYMATIC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 29, 2004. 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.