
Diazyme Laboratories
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DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET is an FDA 510(k)-cleared medical device (K133410) 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 March 13, 2014. Regulation: 8.