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

    ACCUSCREEN TSH

    K Number: K843281 · Decision Sep 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    21
    Review Days
    37

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    Basic Information

    Device Name
    ACCUSCREEN TSH
    K Number
    K843281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Neometrics, Inc.
    Date Received
    August 20, 1984
    Decision Date
    September 26, 1984
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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