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

    SECOND ANTIBODY

    K Number: K781070 · Decision Aug 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    29
    Review Days
    45

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    Basic Information

    Device Name
    SECOND ANTIBODY
    K Number
    K781070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Pcl-Ria, Inc.
    Date Received
    June 26, 1978
    Decision Date
    August 10, 1978
    Product Code
    KTS
    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
    KTS Second Antibody (Species Specific Anti-Animal Gamma Globulin)

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