Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is an FDA 510(k)-cleared medical device (K161646) 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 3, 2016. Regulation: 8.