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

    EKTACHEM DT LDL CHOLESTEROL KIT

    K Number: K955904 · Decision May 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    30
    Applicant Total
    33
    Review Days
    147

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    Basic Information

    Device Name
    EKTACHEM DT LDL CHOLESTEROL KIT
    K Number
    K955904
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    December 29, 1995
    Decision Date
    May 24, 1996
    Product Code
    MRR
    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
    MRR System, Test, Low Density, Lipoprotein

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