510(k) Report

Devices descending from DEN170046

3 later devices reach 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K22359723andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2…23AndMe, Inc.20230—
+1K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc.20220—
+1K182784MUTYH-Associated Polyposis (MAP)23AndMe, Inc.20191—