BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    APAS Independence with Urine Analysis Module

    K Number: K183648 · Decision May 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    APAS Independence with Urine Analysis Module
    K Number
    K183648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2190
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clever Culture Systems AG
    Date Received
    December 26, 2018
    Decision Date
    May 15, 2019
    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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    Other Clearances by Clever Culture Systems AG

    K Number Device Name
    DEN150059 APAS Compact with Urine Analysis Module