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

    LFS LIPOGEL ASSAY KIT

    K Number: K960785 · Decision Sep 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    190

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    Basic Information

    Device Name
    LFS LIPOGEL ASSAY KIT
    K Number
    K960785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zaxis, Inc.
    Date Received
    February 26, 1996
    Decision Date
    September 3, 1996
    Product Code
    JHO
    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
    JHO Electrophoretic Separation, Lipoproteins

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