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

    THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II

    K Number: K911170 · Decision May 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    42
    Review Days
    47

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    Basic Information

    Device Name
    THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
    K Number
    K911170
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Analytical Control Systems, Inc.
    Date Received
    March 15, 1991
    Decision Date
    May 1, 1991
    Product Code
    JIY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JIY Photometric Method, Iron (Non-Heme)

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