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

    CANTROL CK/MB CONTROL

    K Number: K855006 · Decision Jan 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    9
    Review Days
    35

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    Basic Information

    Device Name
    CANTROL CK/MB CONTROL
    K Number
    K855006
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Canyon Diagnostics, Inc.
    Date Received
    December 13, 1985
    Decision Date
    January 17, 1986
    Product Code
    JJT
    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
    JJT Enzyme Controls (Assayed And Unassayed)

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