BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)

    K Number: K023677 · Decision Jan 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
    K Number
    K023677
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osmetech
    Date Received
    November 1, 2002
    Decision Date
    January 29, 2003
    Product Code
    LIB
    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
    LIB Device, General Purpose, Microbiology, Diagnostic

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