BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    OneTouch Delica Plus Lancing System

    K Number: K221546 · Decision Aug 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    OneTouch Delica Plus Lancing System
    K Number
    K221546
    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
    Asahi Polyslider Co., Ltd.
    Date Received
    May 27, 2022
    Decision Date
    August 23, 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 Asahi Polyslider Co., Ltd.

    K Number Device Name
    K222084 OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie