23andMe Personal Genome Service (PGS) Pharmacogenetic Reports— 510(k) DEN180028

Name: FDA 510(k) clearance DEN180028
Creator: U.S. Food and Drug Administration
Published: 2018-10-31

Unknown

23AndMe, Inc.

FDA 510(k) clearance DEN180028 for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports, Unknown on 2018-10-31. Applicant: 23AndMe, Inc.. Device class: 2.

Clearance details

Applicant: 23AndMe, Inc.
Product code: Code QDJ
Device class: Class 2
Regulation: 21 CFR 862.3364
Advisory panel: Medical Genetics
Date received: 2018-06-05
Decision date: 2018-10-31
Decision: Unknown
Clearance type: Direct
Location: Mountain View, CA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.