23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)

23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) is an FDA 510(k)-cleared medical device (DEN140044) manufactured by 23AndMe. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2015. Regulation: 8.