23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is an FDA 510(k)-cleared medical device (K211499) 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 January 5, 2022. Regulation: 8.