23AndMe, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)510(k)Aug 31, 2023Medical Genetics	Medical Genetics	510(k)Substantially Equivalent (Traditional)	Aug 31, 2023
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports510(k)Oct 26, 2022Medical Genetics	Medical Genetics	510(k)Substantially Equivalent (Traditional)	Oct 26, 2022
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)510(k)Jan 6, 2022Medical Genetics	Medical Genetics	510(k)Substantially Equivalent (Traditional)	Jan 6, 2022