
Protos Laboratories
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GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN is an FDA 510(k)-cleared medical device (K791605) manufactured by Protos Laboratories. 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 3, 1979. Regulation: 8.