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

    ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII

    K Number: K844287 · Decision Jan 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    17
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
    K Number
    K844287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Apple Diagnostic Products
    Date Received
    November 5, 1984
    Decision Date
    January 7, 1985
    Product Code
    GLZ
    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
    GLZ Antigens, If, Toxoplasma Gondii

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