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

    FREND Vitamin D Test System

    K Number: K162754 · Decision Jan 12, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    45
    Applicant Total
    5
    Review Days
    104

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    Basic Information

    Device Name
    FREND Vitamin D Test System
    K Number
    K162754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1825
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanoentek USA, Inc.
    Date Received
    September 30, 2016
    Decision Date
    January 12, 2017
    Product Code
    MRG
    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
    MRG System, Test, Vitamin D

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