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

    TOXHA TEST

    K Number: K771560 · Decision Sep 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    17
    Review Days
    31

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    Basic Information

    Device Name
    TOXHA TEST
    K Number
    K771560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Burroughs Wellcome Co.
    Date Received
    August 15, 1977
    Decision Date
    September 15, 1977
    Product Code
    GMM
    Advisory Committee
    Microbiology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GMM Antigens, Iha, Toxoplasma Gondii

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