HOMOCYSTEINE MICROTITER PLATE ASSAY

HOMOCYSTEINE MICROTITER PLATE ASSAY is an FDA 510(k)-cleared medical device (K032012) manufactured by Diazyme Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 2003. Regulation: 8.