BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇭 Switzerland

    APAS Compact with Urine Analysis Module

    K Number: DEN150059 · Decision Oct 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    287

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    Basic Information

    Device Name
    APAS Compact with Urine Analysis Module
    K Number
    DEN150059
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.2190
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Clever Culture Systems AG
    Date Received
    December 24, 2015
    Decision Date
    October 6, 2016
    Product Code
    PPU
    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
    PPU Microbial Colony Image Assessment System

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