CODE QAS 103 ANTI-DNA CONTROLS

CODE QAS 103 ANTI-DNA CONTROLS is an FDA 510(k)-cleared medical device (K791354) manufactured by Amersham Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 1979. Regulation: 8.