The following data is part of a premarket notification filed by 23andme, Inc. with the FDA for 23andme Personal Genome Service (pgs) Pharmacogenetic Reports.
| Device ID | K221885 |
| 510k Number | K221885 |
| Device Name: | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
| Classification | Direct-to-consumer Access Pharmacogenetic 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 | QDJ |
| CFR Regulation Number | 862.3364 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-10-26 |