BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CHEMISTRY CONTROL N & A

    K Number: K855036 · Decision Mar 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    CHEMISTRY CONTROL N & A
    K Number
    K855036
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Integrated Medical Systems Int'L., Inc.
    Date Received
    December 17, 1985
    Decision Date
    March 17, 1986
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Integrated Medical Systems Int'L., Inc.

    K Number Device Name
    K855035 CALIBRATION REFERENCE I & II