BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    eNAT molecular collection and preservation medium

    K Number: K201849 · Decision Sep 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    73

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    Basic Information

    Device Name
    eNAT molecular collection and preservation medium
    K Number
    K201849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2950
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copan Italia Spa
    Date Received
    July 6, 2020
    Decision Date
    September 17, 2020
    Product Code
    QBD
    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
    QBD Microbial Nucleic Acid Storage And Stabilization Device

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