
Kallestad Laboratories, Inc.
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ALLERCOAT ALLERGEN DISCS is an FDA 510(k)-cleared medical device (K852794) manufactured by Kallestad Laboratories, Inc.. 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 18, 1985. Regulation: 8.