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23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)

DEN140044 Class II Direct
Decision Date
2015-02-19
Sponsor / Applicant
23AndMe

Technical Specification

510(k) Submission ID DEN140044
Product Code PKB
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5940
Decision Date 2015-02-19
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) received FDA 510(k) clearance under submission number DEN140044, sponsored by 23AndMe. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-02-19.

Classification & Regulation

This clearance is catalogued under FDA product code PKB and 21 CFR 866.5940, within the Immunology review panel as a Class II device.