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

    Cultura Collection and Transport System

    K Number: K201674 · Decision Mar 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    178
    Review Days
    257

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    Basic Information

    Device Name
    Cultura Collection and Transport System
    K Number
    K201674
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    June 19, 2020
    Decision Date
    March 3, 2021
    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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