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

    HISTOPLASMA CAPSULATUM, ANTISERUM

    K Number: K792711 · Decision Jan 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    92
    Review Days
    21

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    Basic Information

    Device Name
    HISTOPLASMA CAPSULATUM, ANTISERUM
    K Number
    K792711
    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 17, 1980
    Product Code
    GMJ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GMJ Antigens, Histoplasma Capsulatum, All

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