KALLESTAD ANTISERA TO TOBRAMYCIN

KALLESTAD ANTISERA TO TOBRAMYCIN is an FDA 510(k)-cleared medical device (K812415) manufactured by Kallestad Laboratories, Inc.. 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 September 8, 1981. Regulation: 8.