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

    PrimeStore MTM

    K Number: DEN170029 · Decision Mar 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    299

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    Basic Information

    Device Name
    PrimeStore MTM
    K Number
    DEN170029
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.2950
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Longhorn Vaccines and Diagnostics, LLC
    Date Received
    May 24, 2017
    Decision Date
    March 19, 2018
    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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