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

    COCCIDIOIDES IMMITIS, ANTISERUM

    K Number: K792688 · Decision Jan 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    92
    Review Days
    21

    Basic Information

    Device Name
    COCCIDIOIDES IMMITIS, ANTISERUM
    K Number
    K792688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3135
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    MERIDIAN DIAGNOSTICS, INC.
    Date Received
    December 27, 1979
    Decision Date
    January 17, 1980
    Product Code
    GMH
    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
    GMH Antiserum, Positive Control, Coccidioides Immitis

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