BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Sterile Lancet

    K Number: K222246 · Decision Nov 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    Disposable Sterile Lancet
    K Number
    K222246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin Rilifine Medical Device Co., Ltd.
    Date Received
    July 26, 2022
    Decision Date
    November 21, 2022
    Product Code
    QRL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QRL Multiple Use Blood Lancet For Single Patient Use Only

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    Other Clearances by Tianjin Rilifine Medical Device Co., Ltd.

    K Number Device Name
    K222055 Disposable Sterile Lancet