510(k) K082001

DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B by Diazyme Laboratories — Product Code JII

K082001 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code JII (Atomic Absorption, Lithium), a Class II device regulated under 21 CFR 862.3560. Diazyme Laboratories has at least 10 other 510(k) clearances on record.