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

    BD MAX MRSA XT, BD MAX INSTRUMENT

    K Number: K133605 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    25

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    Basic Information

    Device Name
    BD MAX MRSA XT, BD MAX INSTRUMENT
    K Number
    K133605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geneohm Sciences Canada, Inc.
    Date Received
    November 25, 2013
    Decision Date
    December 20, 2013
    Product Code
    NQX
    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
    NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

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