BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    Copan FecalSwab Collection, Transport and Preservation System

    K Number: K220052 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    8
    Review Days
    344

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    Basic Information

    Device Name
    Copan FecalSwab Collection, Transport and Preservation System
    K Number
    K220052
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copan Italia Spa
    Date Received
    January 6, 2022
    Decision Date
    December 16, 2022
    Product Code
    JSM
    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
    JSM Culture Media, Non-Propagating Transport

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    Other Clearances by Copan Italia Spa

    K Number Device Name
    K232565 UriSponge™
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    K180052 UriSwab-Urine Collection, Transport and Preservation System
    K142094 COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
    K972448 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
    K972449 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL