BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TriVerity

    K Number: K241676 · Decision Jan 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    213

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    Basic Information

    Device Name
    TriVerity
    K Number
    K241676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inflammatix, Inc.
    Date Received
    June 11, 2024
    Decision Date
    January 10, 2025
    Product Code
    PRE
    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
    PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

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