Name: Predicase
Price: 199 USD

K-number	DEN160026
Device name	23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
Applicant	23AndMe, Inc.
Product code	PTA
Device class	Class II
Decision date	Apr 6, 2017
Decision	Not Substantially Equivalent
Regulation	866.5950

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

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