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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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De Novo Number: DEN180028 Decision Date To: 04/25/2024
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De Novo
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510(k)
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Decision
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23andMe Personal Genome Service (PGS) Ph 23andMe, Inc. DEN180028 10/31/2018
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