ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS

ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS is an FDA 510(k)-cleared medical device (K930231) manufactured by Alko Diagnostic Corp.. 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 January 12, 1994. Regulation: 8.