BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ARK Voriconazole II Assay Test System

    K Number: DEN160033 · Decision May 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    17
    Review Days
    294

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    Basic Information

    Device Name
    ARK Voriconazole II Assay Test System
    K Number
    DEN160033
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.3970
    Medical Specialty
    Clinical Toxicology
    Decision
    Unknown
    Applicant
    Ark Diagnostics, Inc.
    Date Received
    July 15, 2016
    Decision Date
    May 5, 2017
    Product Code
    PUJ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PUJ Voriconazole Test System

    Other Clearances by Ark Diagnostics, Inc.

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    K200197 ARK Fentanyl II Assay
    K182280 ARK Tramadol Assay
    K182779 ARK EDDP Assay
    K180427 ARK Fentanyl Assay
    K163359 ARK Methotrexate Assay
    K153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
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