Diazyme EZ Vitamin D Assay

Diazyme EZ Vitamin D Assay is an FDA 510(k)-cleared medical device (K172992) 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 January 10, 2018. Regulation: 8.