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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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111 to 120 of 417 results
Decision Date To: 06/21/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
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Decision
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EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 K000280 04/28/2000
Sepax Cell Separation System and Single Biosafe SA BK060036 01/03/2007
TrueGene HIV Genotyping Kit and OpenGene Visible Genetics, Inc. BK000038 06/27/2001
Rho 16 Bit Inc DEN230023 04/09/2024
23ANDME PERSONAL GENOME SERVICE (HEREINA 23andMe DEN140044 02/19/2015
23andMe Personal Genome Service (PGS) Ge 23andMe, Inc. DEN160026 04/06/2017
23andMe PGS Genetic Health Risk Report f 23andMe, Inc. DEN170046 03/06/2018
23andMe Personal Genome Service (PGS) Ph 23andMe, Inc. DEN180028 10/31/2018
3M™ Attest™ eBowie-Dick Test Card 10135 3M Company DEN230068 05/21/2024
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
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