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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