BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BacterioScan 216Dx System

    K Number: K172412 · Decision May 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    BacterioScan 216Dx System
    K Number
    K172412
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bacterioscan, Inc.
    Date Received
    August 10, 2017
    Decision Date
    May 1, 2018
    Product Code
    QBQ
    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
    QBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture