The following data is part of a premarket notification filed by Ancestry Genomics, Inc. with the FDA for Ancestrydna Saliva Collection Kit.
| Device ID | K192947 |
| 510k Number | K192947 |
| Device Name: | AncestryDNA Saliva Collection Kit |
| Classification | Dna Specimen Collection, Saliva |
| Applicant | Ancestry Genomics, Inc. 153 Townsend Street, Suite 800 San Francisco, CA 94107 |
| Contact | Raajdeep Venkatesan |
| Correspondent | Raajdeep Venkatesan Ancestry Genomics, Inc. 153 Townsend Street, Suite 800 San Francisco, CA 94107 |
| Product Code | OYJ |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-18 |
| Decision Date | 2020-08-13 |