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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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261 to 270 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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OraQuick Ebola Rapid Antigen Test OraSure Technologies, Inc. DEN190025 10/10/2019
Sentosa SQ HIV Genotyping Assay Vela Diagnostics USA Inc BR190330 11/05/2019
EchoTip Insight Portosystemic Pressure G Cook Ireland Ltd. DEN180062 11/20/2019
WOUNDCHEK Bacterial Status Alere Scarborough, Inc. DEN180014 12/02/2019
cobas vivoDx MRSA Roche Molecular Systems, Inc. DEN190016 12/05/2019
GSP Neonatal Creatine Kinase - MM kit PerkinElmer Inc. DEN180056 12/12/2019
Control-IQ Technology Tandem Diabetes Care, Inc. DEN190034 12/13/2019
Mucosal Integrity Conductivity (MI) Test Diversatek Healthcare Inc. DEN180067 12/23/2019
Caption Guidance Bay Labs, Inc. DEN190040 02/07/2020
Surfacer Inside-Out Access Catheter Syst Bluegrass Vascular Technologies, Inc. DEN190038 02/10/2020
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