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

    GENZYME DIAGNOSTICS CONTRAST MONO

    K Number: K963425 · Decision Feb 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    179

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    Basic Information

    Device Name
    GENZYME DIAGNOSTICS CONTRAST MONO
    K Number
    K963425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Diagnostics
    Date Received
    August 30, 1996
    Decision Date
    February 25, 1997
    Product Code
    KTN
    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
    KTN System, Test, Infectious Mononucleosis

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    K964155 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST