BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OCTEIA INTACT PTH

    K Number: K941878 · Decision Sep 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    1
    Review Days
    142

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    Basic Information

    Device Name
    OCTEIA INTACT PTH
    K Number
    K941878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I.D.S.
    Date Received
    April 18, 1994
    Decision Date
    September 7, 1994
    Product Code
    CEW
    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
    CEW Radioimmunoassay, Parathyroid Hormone

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