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

    ICA1 IONIZED CALCIUM ANALYZER

    K Number: K801848 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    28
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    ICA1 IONIZED CALCIUM ANALYZER
    K Number
    K801848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The London Co.
    Date Received
    August 4, 1980
    Decision Date
    October 31, 1980
    Product Code
    JFP
    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
    JFP Electrode, Ion Specific, Calcium

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