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

    DISC 120 TRANSPORTER

    K Number: K801391 · Decision Jul 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    206
    Review Days
    31

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    Basic Information

    Device Name
    DISC 120 TRANSPORTER
    K Number
    K801391
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4540
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    June 13, 1980
    Decision Date
    July 14, 1980
    Product Code
    JZW
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    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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