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

    COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

    K Number: K823578 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    49
    Review Days
    32

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    Basic Information

    Device Name
    COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
    K Number
    K823578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hoffmann-La Roche, Inc.
    Date Received
    December 6, 1982
    Decision Date
    January 7, 1983
    Product Code
    CIO
    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
    CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

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