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

    T4 MICROWELL EIA (ENZYME IMMUNOASSAY0

    K Number: K950588 · Decision Jun 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    10
    Review Days
    140

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    Basic Information

    Device Name
    T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
    K Number
    K950588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomerica, Inc.
    Date Received
    February 9, 1995
    Decision Date
    June 29, 1995
    Product Code
    KLI
    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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