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

    Accu-Chek Softclix Blood Lancing System

    K Number: K214022 · Decision Feb 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    9
    Review Days
    57

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    Basic Information

    Device Name
    Accu-Chek Softclix Blood Lancing System
    K Number
    K214022
    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
    Roche Diabetes Care, Inc.
    Date Received
    December 22, 2021
    Decision Date
    February 17, 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 Roche Diabetes Care, Inc.

    K Number Device Name
    K232488 Accu-Chek Safe-T-Pro Plus Lancing Device
    K232509 Accu-Chek Safe-T-Pro Uno Lancing Device
    K220849 Accu-Chek Safe-T-Pro Plus Lancing Device
    K203711 IWL2020 Blood Glucose Monitoring System
    K220608 Accu-Chek FastClix Blood Lancing System
    K220364 Accu-Chek Safe-T-Pro Uno Lancing Device
    K160944 ACCU-CHEK Guide Blood Glucose Monitoring System
    K150910 ACCU-CHEK Connect Diabetes Management App