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

    BD Kiestra IdentifA

    K Number: K222563 · Decision Aug 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    134
    Review Days
    372

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    Basic Information

    Device Name
    BD Kiestra IdentifA
    K Number
    K222563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3378
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    August 24, 2022
    Decision Date
    August 31, 2023
    Product Code
    QQV
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

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