23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)— 510(k) DEN140044

Name: FDA 510(k) clearance DEN140044
Creator: U.S. Food and Drug Administration
Published: 2015-02-19

Unknown

23AndMe

FDA 510(k) clearance DEN140044 for 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS), Unknown on 2015-02-19. Applicant: 23AndMe. Device class: 2.

Clearance details

Applicant: 23AndMe
Product code: Code PKB
Device class: Class 2
Regulation: 21 CFR 866.5940
Advisory panel: Immunology
Date received: 2014-05-29
Decision date: 2015-02-19
Decision: Unknown
Clearance type: Direct
Location: Mountain View, CA, US

View on FDA.gov ↗

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