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

    Puritan Opti-Tranz Cary-Blair Collection and Transport System

    K Number: K160082 · Decision Jul 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    7
    Review Days
    196

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    Basic Information

    Device Name
    Puritan Opti-Tranz Cary-Blair Collection and Transport System
    K Number
    K160082
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puritan Medical Products, LLC
    Date Received
    January 15, 2016
    Decision Date
    July 29, 2016
    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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