FDA 510(k) Applications for Medical Device Product Code "QAZ"

FDA 510(k) Number Applicant Device Name Decision Date
DEN170046 23andMe, Inc. 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 03/06/2018
K211499 23andMe, Inc. 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) 01/06/2022
K223597 23andMe, Inc. 23andMe« Personal Genome Service« (PGS«) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 08/31/2023
K182784 23andMe, Inc. MUTYH-Associated Polyposis (MAP) 01/18/2019


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