DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B

DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B is an FDA 510(k)-cleared medical device (K082001) manufactured by Diazyme Laboratories. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2008. Regulation: 8.