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

    MLX MICROTITER PLATE LUMINOMETER

    K Number: K962265 · Decision Jul 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    52
    Applicant Total
    44
    Review Days
    43

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    Basic Information

    Device Name
    MLX MICROTITER PLATE LUMINOMETER
    K Number
    K962265
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynatech Laboratories, Inc.
    Date Received
    June 12, 1996
    Decision Date
    July 25, 1996
    Product Code
    JSE
    Advisory Committee
    Microbiology
    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
    JSE Culture Media, Multiple Biochemical Test

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