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

    IL TEST IMMUNOGLOBULIN M (IGM)

    K Number: K920008 · Decision Mar 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    321
    Review Days
    69

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    Basic Information

    Device Name
    IL TEST IMMUNOGLOBULIN M (IGM)
    K Number
    K920008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    January 2, 1992
    Decision Date
    March 11, 1992
    Product Code
    CGM
    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
    CGM Method, Immunodiffusion, Immunoglobulins (G, A, M)

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