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

    CHAGAS' IGG ELISA TEST

    K Number: K911233 · Decision May 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    57
    Review Days
    411

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    Basic Information

    Device Name
    CHAGAS' IGG ELISA TEST
    K Number
    K911233
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gull Laboratories, Inc.
    Date Received
    March 20, 1991
    Decision Date
    May 4, 1992
    Product Code
    MIU
    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
    MIU Enzyme Linked Immunosorbent Assay, T. Cruzi

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