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

    C. PTH RADIOIMMUNOASSAY KIT-CPTHK

    K Number: K833768 · Decision Dec 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    20
    Review Days
    63

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    Basic Information

    Device Name
    C. PTH RADIOIMMUNOASSAY KIT-CPTHK
    K Number
    K833768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    October 27, 1983
    Decision Date
    December 29, 1983
    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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