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

    FREND™ Free T4 Test System

    K Number: K152422 · Decision Feb 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    5
    Review Days
    175

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FREND™ Free T4 Test System
    K Number
    K152422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanoentek USA, Inc.
    Date Received
    August 26, 2015
    Decision Date
    February 17, 2016
    Product Code
    CEC
    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
    CEC Radioimmunoassay, Free Thyroxine

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CEC), ordered by most recent decision date.

    Access Free T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys FT4 IV

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAGLUMI 2000 FT4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys FT4 III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Abbott Architect Free T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VIDAS FT4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Nanoentek USA, Inc.

    K Number Device Name
    K162378 FREND PSA PLUS (reagent cartridge)
    K162754 FREND Vitamin D Test System
    K153577 FREND Testosterone Test System
    K131928 FREND TSH (REAGENT CARTRIDGE)