The following data is part of a premarket notification filed by 23andme, Inc. with the FDA for 23andme Pgs Genetic Risk Report For Hereditary Prostate Cancer (hoxb13-related).
| Device ID | K211499 |
| 510k Number | K211499 |
| Device Name: | 23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related) |
| Classification | Cancer Predisposition Risk Assessment System |
| Applicant | 23andMe, Inc. 349 Oyster Point Blvd. South San Francisco, CA 94080 |
| Contact | Marianna Frendo |
| Correspondent | Marianna Frendo 23andMe, Inc. 349 Oyster Point Blvd. South San Francisco, CA 94080 |
| Product Code | QAZ |
| CFR Regulation Number | 866.6090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2022-01-06 |