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

    LDL-EX SEIKEN ASSAY KIT

    K Number: K043264 · Decision Jan 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    30
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    LDL-EX SEIKEN ASSAY KIT
    K Number
    K043264
    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
    November 24, 2004
    Decision Date
    January 26, 2005
    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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    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
    K041090 HDL-EX SEIKEN ASSAY KIT
    K030545 CRP-LATEX (II)X2 SEIKEN ASSAY KIT
    K030546 CRP (II) CALIBRATORS