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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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91 to 100 of 413 results
Decision Date To: 05/18/2024
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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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Simple 2 Test LetsGetChecked Inc. (formerly PrivaPath DEN200070 11/15/2023
Cognoa ASD Diagnosis Aid Cognoa, Inc. DEN200069 06/02/2021
INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products DEN200067 09/29/2022
BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066 04/29/2022
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059 01/21/2022
GI Genius Cosmo Artificial Intelligence - AI, LTD DEN200055 04/09/2021
KidneyIntelX.dkd Renalytix AI, Inc. DEN200052 06/29/2023
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