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

    HY-PREP SYSTEM

    K Number: K913809 · Decision Jan 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    139
    Applicant Total
    8
    Review Days
    142

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    Basic Information

    Device Name
    HY-PREP SYSTEM
    K Number
    K913809
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2750
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hyperion, Inc.
    Date Received
    August 26, 1991
    Decision Date
    January 15, 1992
    Product Code
    JQW
    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
    JQW Station, Pipetting And Diluting, For Clinical Use

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