MONOCLONAL ANTIBODY T4 RADIO-KIT

MONOCLONAL ANTIBODY T4 RADIO-KIT is an FDA 510(k)-cleared medical device (K823265) 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 December 8, 1982. Regulation: 8.