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

    PPH Saliva Collection Kit

    K Number: K240797 · Decision Oct 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    PPH Saliva Collection Kit
    K Number
    K240797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2950
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Permantis Public Health
    Date Received
    March 22, 2024
    Decision Date
    October 11, 2024
    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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