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

    CALCITONIN IMMUNOASSAY KIT

    K Number: K945961 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    18
    Applicant Total
    68
    Review Days
    348

    Basic Information

    Device Name
    CALCITONIN IMMUNOASSAY KIT
    K Number
    K945961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Received
    December 7, 1994
    Decision Date
    November 20, 1995
    Product Code
    JKR
    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
    JKR Radioimmunoassay, Calcitonin

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