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

    Accelerate Pheno System, Accelerate PhenoTest BC Kit

    K Number: K192665 · Decision Sep 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    356

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    Basic Information

    Device Name
    Accelerate Pheno System, Accelerate PhenoTest BC Kit
    K Number
    K192665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accelerate Diagnostics, Inc.
    Date Received
    September 25, 2019
    Decision Date
    September 15, 2020
    Product Code
    PRH
    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
    PRH Positive Blood Culture Identification And Ast Kit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PRH), ordered by most recent decision date.

    Accelerate Pheno system, Accelerate Phenotest BC Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Accelerate Diagnostics, Inc.

    K Number Device Name
    K240854 Accelerate Arc System