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

    CALCITONIN

    K Number: K990073 · Decision May 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    120

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    Basic Information

    Device Name
    CALCITONIN
    K Number
    K990073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kmi Diagnostics, Inc.
    Date Received
    January 11, 1999
    Decision Date
    May 11, 1999
    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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