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

    MedtFine Blood Lancet

    K Number: K221383 · Decision Sep 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    131

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    Basic Information

    Device Name
    MedtFine Blood Lancet
    K Number
    K221383
    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
    Shanghai Carelife International Trading Co. , Ltd.
    Date Received
    May 13, 2022
    Decision Date
    September 21, 2022
    Product Code
    QRK
    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
    QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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    Other Clearances by Shanghai Carelife International Trading Co. , Ltd.

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