FOLATE REAGENT KIT, ARIA-II SYSTEM

FOLATE REAGENT KIT, ARIA-II SYSTEM is an FDA 510(k)-cleared medical device (K780557) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 May 17, 1978. Regulation: 8.