23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is an FDA 510(k)-cleared medical device (K221885) 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 October 25, 2022. Regulation: 8.