23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)— 510(k) DEN170046

Name: FDA 510(k) clearance DEN170046
Creator: U.S. Food and Drug Administration
Published: 2018-03-06

Unknown

23AndMe, Inc.

FDA 510(k) clearance DEN170046 for 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), Unknown on 2018-03-06. Applicant: 23AndMe, Inc.. Device class: 2.

Clearance details

Applicant: 23AndMe, Inc.
Product code: Code QAZ
Device class: Class 2
Regulation: 21 CFR 866.6090
Advisory panel: Medical Genetics
Date received: 2017-09-05
Decision date: 2018-03-06
Decision: Unknown
Clearance type: Direct
Location: Mountain View, CA, US

View on FDA.gov ↗

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K182784 — MUTYH-Associated Polyposis (MAP)2019-01-18

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