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

    BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA

    K Number: K903626 · Decision Oct 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    29
    Applicant Total
    281
    Review Days
    66

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    Basic Information

    Device Name
    BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
    K Number
    K903626
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Beckman Instruments, Inc.
    Date Received
    August 10, 1990
    Decision Date
    October 15, 1990
    Product Code
    JJG
    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
    JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

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