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

    Greiner Vacuette Urine Count and Culture, Mannitol tube

    K Number: K163436 · Decision Mar 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    Greiner Vacuette Urine Count and Culture, Mannitol tube
    K Number
    K163436
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Greiner Bio-One Na, Inc.
    Date Received
    December 7, 2016
    Decision Date
    March 6, 2017
    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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