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    K Number
    K962265
    Device Name
    MLX MICROTITER PLATE LUMINOMETER
    Manufacturer
    DYNATECH LABORATORIES, INC.
    Date Cleared
    1996-07-25

    (43 days)

    Product Code
    JSE
    Regulation Number
    866.2320
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNATECH LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MLX measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results.
    Device Description
    The MLX Microtiter® Plate Luminometer ("MLX") measures the light emitted from bioluminescent and chemiluminescent reactions samples, performs defined test protocols and allows selection of various forms of output formats of the test results. The Revelation software incorporated in the MLX was developed and manufactured in accordance with comprehensive software development, validation and verification procedures.
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