BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NOVACYTE-U

    K Number: K862665 · Decision Sep 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    52

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    Basic Information

    Device Name
    NOVACYTE-U
    K Number
    K862665
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3250
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Xsirius Medical, Inc.
    Date Received
    July 14, 1986
    Decision Date
    September 4, 1986
    Product Code
    KDT
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDT Container, Specimen Mailer And Storage, Sterile

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