DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS

DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS is an FDA 510(k)-cleared medical device (K102638) 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 November 29, 2010. Regulation: 8.