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

    IQ CALCIUM

    K Number: K891217 · Decision May 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    98
    Applicant Total
    632
    Review Days
    57

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    Basic Information

    Device Name
    IQ CALCIUM
    K Number
    K891217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    March 7, 1989
    Decision Date
    May 3, 1989
    Product Code
    CIC
    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
    CIC Cresolphthalein Complexone, Calcium

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