23andMe Genomics LLC

FDA Device Registration & Listing · Palo Alto, CA, US · Registration 3007699459

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007699459
FEI Number
3007699459
Entity Name
23andMe Genomics LLC
City/State/Country
Palo Alto, CA, US
Establishment Address
2555 Park Blvd, Palo Alto, CA 94306, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
23andMe Genomics LLC (Owner Number: 10029404)
Owner / Operator Contact Address
2555 Park Boulevard, Palo Alto, CA 94306, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182784
PMA Number
N/A

All Registered Proprietary Names

Cancer predisposition risk assessment system 23andMe Pharmacogenetics Reports DNA specimen collection, saliva 23andMe BRCA1/BRCA2 (Selected Variants) Report 23andMe Personal Genome Service Pharmacogenetics Reports Autosomal recessive carrier screening gene mutation detection system Cancer predisposition risk assessment system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAZ Cancer Predisposition Risk Assessment System Medical Genetics Class 2 866.6090 2018-03-06
QDJ Direct-To-Consumer Access Pharmacogenetic Assessment System Medical Genetics Class 2 862.3364 2023-11-27
OYJ Dna Specimen Collection, Saliva Clinical Chemistry Class 2 862.1675 2019-02-08
QAZ Cancer Predisposition Risk Assessment System Medical Genetics Class 2 866.6090 2023-11-27
QDJ Direct-To-Consumer Access Pharmacogenetic Assessment System Medical Genetics Class 2 862.3364 2021-01-28
PKB Autosomal Recessive Carrier Screening Gene Mutation Detection System Immunology Class 2 866.5940 2015-10-20
QAZ Cancer Predisposition Risk Assessment System Medical Genetics Class 2 866.6090 2019-02-08

Official Correspondent

Mark Pisaro

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

23andMe Genomics LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007699459. Last updated year: 2026. Please use registration number 3007699459 when referencing this establishment in official correspondence.
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