BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT

    K Number: K884201 · Decision Dec 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    24
    Applicant Total
    17
    Review Days
    69

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    Basic Information

    Device Name
    FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
    K Number
    K884201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1685
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cyberfluor, Inc.
    Date Received
    October 6, 1988
    Decision Date
    December 14, 1988
    Product Code
    CEE
    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
    CEE Radioimmunoassay, Thyroxine-Binding Globulin

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