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

    BioFire Blood Culture Identification 2 (BCID2) Panel

    K Number: K193519 · Decision Mar 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    28
    Review Days
    90

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    Basic Information

    Device Name
    BioFire Blood Culture Identification 2 (BCID2) Panel
    K Number
    K193519
    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, LLC
    Date Received
    December 19, 2019
    Decision Date
    March 18, 2020
    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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