BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    TURBOX

    K Number: K873401 · Decision Sep 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    73
    Review Days
    30

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    Basic Information

    Device Name
    TURBOX
    K Number
    K873401
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4540
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Unipath , Ltd.
    Date Received
    August 24, 1987
    Decision Date
    September 23, 1987
    Product Code
    JZW
    Advisory Committee
    Immunology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZW Nephelometer

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