BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SAC-CEL

    K Number: K813508 · Decision Dec 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    17
    Review Days
    14

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    Basic Information

    Device Name
    SAC-CEL
    K Number
    K813508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Burroughs Wellcome Co.
    Date Received
    December 15, 1981
    Decision Date
    December 29, 1981
    Product Code
    KTS
    Advisory Committee
    Immunology
    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
    KTS Second Antibody (Species Specific Anti-Animal Gamma Globulin)

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