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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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231 to 240 of 412 results
Decision Date To: 05/03/2024
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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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Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation DEN170080 09/28/2018
Bose Hearing Aid Bose Corporation DEN180026 10/05/2018
picoAMH ELISA Ansh Labs LLC DEN180004 10/24/2018
23andMe Personal Genome Service (PGS) Ph 23andMe, Inc. DEN180028 10/31/2018
Parathyroid Detection (Model PTeye) Syst AiBiomed, Corp. DEN170056 11/02/2018
Fluobeam 800 Clinic Imaging Device used Fluoptics DEN170092 11/02/2018
Innovo Bio-Medical Research Ltd. DEN170049 11/06/2018
QMS Plazomicin Immunoassay Microgenics Corporation DEN180030 11/19/2018
Alethia CMV DNA Amplification Assay, Ale Meridian Bioscience, Inc. DEN180040 11/30/2018
Retrograde Intubation Set Cook Incorporated DEN170055 12/12/2018
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