BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇪 Ireland

    Simple 2 Test

    K Number: DEN200070 · Decision Nov 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    1094

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    Basic Information

    Device Name
    Simple 2 Test
    K Number
    DEN200070
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3385
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)
    Date Received
    November 16, 2020
    Decision Date
    November 15, 2023
    Product Code
    QYA
    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
    QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

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