BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EASYDEX

    K Number: K120247 · Decision Jun 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    146

    Basic Information

    Device Name
    EASYDEX
    K Number
    K120247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VINELAND SYRUP INC.
    Date Received
    January 27, 2012
    Decision Date
    June 21, 2012
    Product Code
    MRV
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRV Drink, Glucose Tolerance

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