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

    TSH RECEPTOR ANTIBODY KIT 125I TSH

    K Number: K841580 · Decision Oct 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    9
    Review Days
    188

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    Basic Information

    Device Name
    TSH RECEPTOR ANTIBODY KIT 125I TSH
    K Number
    K841580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Clinetics Corp.
    Date Received
    April 17, 1984
    Decision Date
    October 22, 1984
    Product Code
    JZO
    Advisory Committee
    Immunology
    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
    JZO System, Test, Thyroid Autoantibody

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    K823379 125-I FSH RADIOIMMUNOASSAY KIT
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