MACRO-VUE CARD TEST, AMIKACIN

MACRO-VUE CARD TEST, AMIKACIN is an FDA 510(k)-cleared medical device (K821771) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 June 24, 1982. Regulation: 8.