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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: DEN200001 Decision Date To: 10/31/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Cell-Free DNA BCT Streck, Inc. DEN200001 08/07/2020
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