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

    FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

    K Number: K130914 · Decision Jun 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
    K Number
    K130914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics, Inc.
    Date Received
    April 2, 2013
    Decision Date
    June 21, 2013
    Product Code
    PEN
    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
    PEN Gram-Negative Bacteria And Associated Resistance Markers

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    Other Clearances by Biofire Diagnostics, Inc.

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