BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

    K Number: K213280 · Decision May 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    580

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    Basic Information

    Device Name
    BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
    K Number
    K213280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2190
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Kiestra B.V.
    Date Received
    October 1, 2021
    Decision Date
    May 4, 2023
    Product Code
    QQY
    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
    QQY Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QQY), ordered by most recent decision date.

    APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module

    FDA 510(k)
    FDA Class 2 ·Microbiology
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