The following data is part of a premarket notification filed by 23andme, Inc. with the FDA for Mutyh-associated Polyposis (map).
| Device ID | K182784 |
| 510k Number | K182784 |
| Device Name: | MUTYH-Associated Polyposis (MAP) |
| Classification | Cancer Predisposition Risk Assessment System |
| Applicant | 23andMe, Inc. 899 W. Evelyn Ave., CA Mountain View, CA 94041 |
| Contact | Sarah Rys |
| Correspondent | Sarah Rys 23andMe, Inc. 899 W. Evelyn Ave., CA Mountain View, CA 94041 |
| Product Code | QAZ |
| CFR Regulation Number | 866.6090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2019-01-18 |
| Summary: | summary |