COAT-A-COUNT AMIKACIN IRA

COAT-A-COUNT AMIKACIN IRA is an FDA 510(k)-cleared medical device (K820781) manufactured by Diagnostic Products Corp.. 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 April 8, 1982. Regulation: 8.