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Phadia AB
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IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 is an FDA 510(k)-cleared medical device (K092050) manufactured by Phadia AB. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2009. Regulation: 8.