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

    FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM

    K Number: K851450 · Decision Sep 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
    K Number
    K851450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Flow Cytometry Standards Corp.
    Date Received
    April 11, 1985
    Decision Date
    September 16, 1985
    Product Code
    JIW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JIW Calibrator, Surrogate

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