23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia— 510(k) DEN160026

Name: FDA 510(k) clearance DEN160026
Creator: U.S. Food and Drug Administration
Published: 2017-04-06

Unknown

23AndMe, Inc.

FDA 510(k) clearance DEN160026 for 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia, Unknown on 2017-04-06. Applicant: 23AndMe, Inc.. Device class: 2.

Clearance details

Applicant: 23AndMe, Inc.
Product code: Code PTA
Device class: Class 2
Regulation: 21 CFR 866.5950
Advisory panel: Immunology
Date received: 2016-06-28
Decision date: 2017-04-06
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.