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

    Accelerate Pheno system, Accelerate Phenotest BC Kit

    K Number: DEN160032 · Decision Feb 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    Accelerate Pheno system, Accelerate Phenotest BC Kit
    K Number
    DEN160032
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.1650
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Accelerate Diagnotics
    Date Received
    July 11, 2016
    Decision Date
    February 23, 2017
    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.

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