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

    LIPOPRINT SYSTEM, LDL SUBFRACTIONS

    K Number: K010337 · Decision Jul 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    38
    Review Days
    170

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    Basic Information

    Device Name
    LIPOPRINT SYSTEM, LDL SUBFRACTIONS
    K Number
    K010337
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantimetrix Corp.
    Date Received
    February 5, 2001
    Decision Date
    July 25, 2001
    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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    MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

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    MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

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    SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343

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