BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    ARK Methotrexate Assay

    K Number: K163359 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    17
    Review Days
    261

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    Basic Information

    Device Name
    ARK Methotrexate Assay
    K Number
    K163359
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ark Diagnostics, Inc.
    Date Received
    November 30, 2016
    Decision Date
    August 18, 2017
    Product Code
    LAO
    Advisory Committee
    Unknown
    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
    LAO Enzyme Immunoassay, Methotrexate

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