BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

    K Number: K201017 · Decision Oct 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    549

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    Basic Information

    Device Name
    BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
    K Number
    K201017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3975
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geneohm Sciences Canada, Inc. (Bd Life Sciences)
    Date Received
    April 17, 2020
    Decision Date
    October 18, 2021
    Product Code
    PQA
    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
    PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

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