DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT is an FDA 510(k)-cleared medical device (K042448) manufactured by General Atomics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 28, 2004. Regulation: 8.