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

    MICROZYME T3 ENZYME IMMUNOASSAY KIT

    K Number: K904820 · Decision Dec 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    37
    Review Days
    55

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    Basic Information

    Device Name
    MICROZYME T3 ENZYME IMMUNOASSAY KIT
    K Number
    K904820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immunotech Corp.
    Date Received
    October 24, 1990
    Decision Date
    December 18, 1990
    Product Code
    CDP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CDP Radioimmunoassay, Total Triiodothyronine

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