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

    T2CANDIDA AND T2DX INSTRUMENT

    K Number: DEN140019 · Decision Sep 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    118

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    Basic Information

    Device Name
    T2CANDIDA AND T2DX INSTRUMENT
    K Number
    DEN140019
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3960
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    T2biosystems, Inc.
    Date Received
    May 27, 2014
    Decision Date
    September 22, 2014
    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 1.1 Panel

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    Other Clearances by T2biosystems, Inc.

    K Number Device Name
    K234063 T2Candida 1.1 Panel
    K233184 T2Bacteria® Panel
    K231336 T2 Biothreat Panel
    K172708 T2Bacteria Panel
    K173536 T2Candida 1.1 Panel