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

    Accelerate Arc System

    K Number: K240854 · Decision Sep 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    182

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    Basic Information

    Device Name
    Accelerate Arc System
    K Number
    K240854
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3378
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accelerate Diagnostics, Inc.
    Date Received
    March 28, 2024
    Decision Date
    September 26, 2024
    Product Code
    QNJ
    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
    QNJ Mass Spectrometry, Microorganism Identification, Blood Culture

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    Other Clearances by Accelerate Diagnostics, Inc.

    K Number Device Name
    K192665 Accelerate Pheno System, Accelerate PhenoTest BC Kit