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

    FREE T4 MICROWELL EIA, MODEL #7019

    K Number: K982954 · Decision Sep 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    10
    Review Days
    31

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    Basic Information

    Device Name
    FREE T4 MICROWELL EIA, MODEL #7019
    K Number
    K982954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomerica, Inc.
    Date Received
    August 24, 1998
    Decision Date
    September 24, 1998
    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

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