23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is an FDA 510(k)-cleared medical device (DEN170046) manufactured by 23AndMe, Inc.. This device is classified under the Medical Genetics specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2018. Regulation: 8.