BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

    K Number: DEN240067 · Decision Sep 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    301

    Basic Information

    Device Name
    KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
    K Number
    DEN240067
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.1885
    Medical Specialty
    Hematology
    Decision
    Unknown
    Applicant
    Cytocell Limited
    Date Received
    November 22, 2024
    Decision Date
    September 19, 2025
    Product Code
    SFS
    Advisory Committee
    Hematology
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SFS Revumenib Eligibility Detection System