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

    REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

    K Number: K894366 · Decision Aug 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    280
    Review Days
    48

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    Basic Information

    Device Name
    REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
    K Number
    K894366
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    July 14, 1989
    Decision Date
    August 31, 1989
    Product Code
    LBT
    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
    LBT Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

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