K-number	DEN180028
Device name	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant	23AndMe, Inc.
Product code	QDJ
Device class	Class II
Decision date	Oct 31, 2018
Decision	Not 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

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