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23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

DEN160026 Class II Direct
Decision Date
2017-04-06
Sponsor / Applicant
23AndMe, Inc.

Technical Specification

510(k) Submission ID DEN160026
Product Code PTA
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5950
Decision Date 2017-04-06
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 (PGS) Genetic Health Risk Test for Hereditary Thrombophilia received FDA 510(k) clearance under submission number DEN160026, sponsored by 23AndMe, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2017-04-06.

Classification & Regulation

This clearance is catalogued under FDA product code PTA and 21 CFR 866.5950, within the Immunology review panel as a Class II device.