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

    DUPONT PREP FOUR-SOLVENT RETROFIT KIT

    K Number: K851393 · Decision Jul 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    14
    Applicant Total
    253
    Review Days
    94

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    Basic Information

    Device Name
    DUPONT PREP FOUR-SOLVENT RETROFIT KIT
    K Number
    K851393
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    April 9, 1985
    Decision Date
    July 12, 1985
    Product Code
    JJH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJH Clinical Sample Concentrator

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