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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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1 to 10 of 412 results
Decision Date To: 04/29/2024
 
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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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
Vitamin D 200M Assay for the Topaz Syste AB SCIEX LLC DEN170019 05/18/2017
CADScor System Acarix A/S DEN190047 11/24/2020
Accelerate Pheno system, Accelerate Phen ACCELERATE DIAGNOTICS DEN160032 02/23/2017
Acclarent Aera Eustachian Tube Balloon D ACCLARENT, INC. DEN150056 09/16/2016
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
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