BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    NANOSEP N10

    K Number: K935496 · Decision Apr 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    162

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    Basic Information

    Device Name
    NANOSEP N10
    K Number
    K935496
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2310
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intersep , Ltd.
    Date Received
    November 15, 1993
    Decision Date
    April 26, 1994
    Product Code
    JJH
    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
    JJH Clinical Sample Concentrator

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