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

    Chagas Detect Plus Rapid Test

    K Number: K161947 · Decision Dec 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    155

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    Basic Information

    Device Name
    Chagas Detect Plus Rapid Test
    K Number
    K161947
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    InBios International, Inc.
    Date Received
    July 14, 2016
    Decision Date
    December 16, 2016
    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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