ARIA II I-HCG

ARIA II I-HCG is an FDA 510(k)-cleared medical device (K830997) 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 June 1, 1983. Regulation: 8.