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

    T2Candida 1.1 Panel

    K Number: K234063 · Decision Sep 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    266

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    Basic Information

    Device Name
    T2Candida 1.1 Panel
    K Number
    K234063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3960
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    T2biosystems, Inc.
    Date Received
    December 22, 2023
    Decision Date
    September 13, 2024
    Product Code
    PII
    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
    PII Candida Species Nucleic Acid Detection System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PII), ordered by most recent decision date.

    T2Candida 1.1 Panel

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    T2CANDIDA AND T2DX INSTRUMENT

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    Other Clearances by T2biosystems, Inc.

    K Number Device Name
    K233184 T2Bacteria® Panel
    K231336 T2 Biothreat Panel
    K172708 T2Bacteria Panel
    K173536 T2Candida 1.1 Panel
    DEN140019 T2CANDIDA AND T2DX INSTRUMENT