K-number	K221885
Device name	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant	23AndMe, Inc.
Product code	QDJ
Device class	Class II
Decision date	Oct 26, 2022
Decision	Substantially Equivalent
Regulation	862.3364

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Source

View the full FDA submission: accessdata.fda.gov

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23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

Everything you need for a 510(k) submission. Nothing you don't.