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

    CAPTIA MEASLES IGM

    K Number: K140455 · Decision May 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    11
    Review Days
    87

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    Basic Information

    Device Name
    CAPTIA MEASLES IGM
    K Number
    K140455
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3520
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Biotech USA
    Date Received
    February 24, 2014
    Decision Date
    May 22, 2014
    Product Code
    PCL
    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
    PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm

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