BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇯🇵 Japan

    HDL-EX SEIKEN ASSAY KIT

    K Number: K041090 · Decision Oct 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    79
    Applicant Total
    6
    Review Days
    186

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    Basic Information

    Device Name
    HDL-EX SEIKEN ASSAY KIT
    K Number
    K041090
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denka Seiken Co., Ltd.
    Date Received
    April 26, 2004
    Decision Date
    October 29, 2004
    Product Code
    LBS
    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
    LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

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    Other Clearances by Denka Seiken Co., Ltd.

    K Number Device Name
    K161679 s LDL-EX SEIKEN
    K060359 ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
    K043264 LDL-EX SEIKEN ASSAY KIT
    K030545 CRP-LATEX (II)X2 SEIKEN ASSAY KIT
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