DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls

DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls is an FDA 510(k)-cleared medical device (K150502) manufactured by Microgenics Corporation. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 2015. Regulation: 8.