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

    LabPro Data Management System

    K Number: K201405 · Decision Aug 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    288
    Applicant Total
    270
    Review Days
    94

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    Basic Information

    Device Name
    LabPro Data Management System
    K Number
    K201405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    May 28, 2020
    Decision Date
    August 30, 2020
    Product Code
    LON
    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
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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