Name: Predicase
Price: 199 USD

K-number	DEN170046
Device name	23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Applicant	23AndMe, Inc.
Product code	QAZ
Device class	Class II
Decision date	Mar 6, 2018
Decision	Not Substantially Equivalent
Regulation	866.6090

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

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