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

    WELLPREP 1

    K Number: K913567 · Decision Oct 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    139
    Applicant Total
    9
    Review Days
    56

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    Basic Information

    Device Name
    WELLPREP 1
    K Number
    K913567
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2750
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Denley Instruments, Inc.
    Date Received
    August 9, 1991
    Decision Date
    October 4, 1991
    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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