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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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171 to 180 of 413 results
Decision Date To: 05/17/2024
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Device Name
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De Novo
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510(k)
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Decision
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SEEKER System Baebies, Inc. DEN150035 02/03/2017
Variola virus Real-Time PCR Assay CENTERS FOR DISEASE CONTROL AND PREVENTI DEN160016 02/06/2017
FilmArray NGDS Warrior Panel BioFire Defense, LLC DEN160048 02/14/2017
Companion LGCH, INC DEN140033 02/16/2017
Accelerate Pheno system, Accelerate Phen ACCELERATE DIAGNOTICS DEN160032 02/23/2017
CINtec Histology (50 tests), CINtec Hist VENTANA MEDICAL SYSTEMS, INC DEN160019 03/04/2017
ipsogen JAK2 RGQ PCR Kit QIAGEN INC DEN160028 03/27/2017
23andMe Personal Genome Service (PGS) Ge 23andMe, Inc. DEN160026 04/06/2017
Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. DEN160056 04/12/2017
gammaCore Non-invasive Vagus Nerve Stimu electroCore, LLC DEN150048 04/14/2017
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