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23AndMe, Inc.
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23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia is an FDA 510(k)-cleared medical device (DEN160026) manufactured by 23AndMe, 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 April 5, 2017. Regulation: 8.