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

    V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT

    K Number: K854971 · Decision Feb 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    22
    Review Days
    57

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    Basic Information

    Device Name
    V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
    K Number
    K854971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    V-Tech, Inc.
    Date Received
    December 11, 1985
    Decision Date
    February 6, 1986
    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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    K910738 TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
    K910122 TARGET COCAINE METABOLITE-R
    K910123 TARGET COCAINE METABOLITE-V
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