510(k) K221885
- Device
- 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Applicant
- 23andMe, Inc.
- 510(k) number
- K221885
- Product code
- QDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-26
- Date received
- 2022-06-29
- Regulation
- 862.3364
- Classification name
- Direct-to-consumer Access Pharmacogenetic Assessment System
- Medical specialty
- Molecular Genetics
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Marianna Frendo
- Address
- 349 Oyster Pt. Blvd. San Franciso CA US 94080 94080
FDA Registration Numbers#
- 3007699459
Source Documents#
Other 510(k) Records For Product Code QDJ #
Legacy Summary#
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FDA Review#
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