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

    HEMAGEN CHAGAS' KIT (EIA METHOD)

    K Number: K930272 · Decision May 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    52
    Review Days
    850

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    Basic Information

    Device Name
    HEMAGEN CHAGAS' KIT (EIA METHOD)
    K Number
    K930272
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemagen Diagnostics, Inc.
    Date Received
    January 19, 1993
    Decision Date
    May 19, 1995
    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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