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

    IMMUNODIFFUSION BAND INTENSIFYING FLUID

    K Number: K792692 · Decision Jan 24, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    92
    Review Days
    28

    Basic Information

    Device Name
    IMMUNODIFFUSION BAND INTENSIFYING FLUID
    K Number
    K792692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    MERIDIAN DIAGNOSTICS, INC.
    Date Received
    December 27, 1979
    Decision Date
    January 24, 1980
    Product Code
    GMK
    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
    GMK Antiserum, Positive Control, Histoplasma Capsulatum

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