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

    Teal Wand

    K Number: DEN240045 · Decision May 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    255

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    Basic Information

    Device Name
    Teal Wand
    K Number
    DEN240045
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.2920
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Teal Health, Inc.
    Date Received
    August 27, 2024
    Decision Date
    May 9, 2025
    Product Code
    SEP
    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
    SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

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