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

    binx health io CT/NG Assay

    K Number: K191352 · Decision Aug 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    binx health io CT/NG Assay
    K Number
    K191352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3393
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Binx Health, Inc.
    Date Received
    May 20, 2019
    Decision Date
    August 8, 2019
    Product Code
    QEP
    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
    QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

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    Other Clearances by Binx Health, Inc.

    K Number Device Name
    K200533 binx io CT/NG Assay and binx io CT/NG System