BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    RANDOX CALCIUM

    K Number: K000375 · Decision Apr 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    98
    Applicant Total
    110
    Review Days
    58

    Basic Information

    Device Name
    RANDOX CALCIUM
    K Number
    K000375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RANDOX LABORATORIES, LTD.
    Date Received
    February 7, 2000
    Decision Date
    April 5, 2000
    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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