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

    Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

    K Number: K213146 · Decision Oct 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    1
    Review Days
    760

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    Basic Information

    Device Name
    Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
    K Number
    K213146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jiangsu Rongye Technology Co., Ltd.
    Date Received
    September 27, 2021
    Decision Date
    October 27, 2023
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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