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

    DENLEY WELLPREP 2 SAMPLE PROCESSOR

    K Number: K922327 · Decision Aug 12, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    139
    Applicant Total
    9
    Review Days
    93

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    Basic Information

    Device Name
    DENLEY WELLPREP 2 SAMPLE PROCESSOR
    K Number
    K922327
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2750
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denley Instruments, Inc.
    Date Received
    May 11, 1992
    Decision Date
    August 12, 1992
    Product Code
    JQW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    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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