510(k) K053566

MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A by Diazyme Laboratories — Product Code MZV

K053566 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A". The FDA issued a decision of Substantially Equivalent on February 15, 2006. 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.