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

    MEASLESVIRUS FLOURE. CONJUGATED ANTISERU

    K Number: K770687 · Decision Jun 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    62

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    Basic Information

    Device Name
    MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
    K Number
    K770687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3520
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbiological Assoc.
    Date Received
    April 13, 1977
    Decision Date
    June 14, 1977
    Product Code
    GRE
    Advisory Committee
    Microbiology
    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
    GRE Antiserum, Fluorescent, Rubeola

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