BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DAT TEST FOR CHAGAS' DISEASE

    K Number: K834328 · Decision Mar 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    84

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    Basic Information

    Device Name
    DAT TEST FOR CHAGAS' DISEASE
    K Number
    K834328
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Sero-Immuno Diagnostics, Inc.
    Date Received
    December 9, 1983
    Decision Date
    March 2, 1984
    Product Code
    GNE
    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
    GNE Antigen, Latex Agglutination, T. Cruzi

    Other Clearances by Sero-Immuno Diagnostics, Inc.

    K Number Device Name
    K852286 DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
    K842181 BETA-HCG HEMAGGLUTINATION TEST