BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    STAPHAUREX PLUS(TM)

    K Number: K945538 · Decision Jun 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    199

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    Basic Information

    Device Name
    STAPHAUREX PLUS(TM)
    K Number
    K945538
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Murex Diagnostics Limitd
    Date Received
    November 14, 1994
    Decision Date
    June 1, 1995
    Product Code
    JWX
    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
    JWX Kit, Screening, Staphylococcus Aureus

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