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    K Number
    K991263
    Device Name
    THERMOPLATE
    Manufacturer
    TOKAI HIT CO., LTD.
    Date Cleared
    1999-07-08

    (86 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKAI HIT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THERMOPLATE is a Stage Warmer which is used to control the temperature of specimens such as gametes and embryos observed under a microscope.
    Device Description
    The THERMOPLATE is a device automatically controls the temperature of specimens under the microscopes. The THERMOPLATE is made up of two sections: the plate section and the controller section. The plate section is to be set on the stage of a microscope. The specimen placed on the plate section can be maintained at an optimum temperature by the function of the heating element and the heating control unit. As a clear heating material is being coated inside the plate section, sufficient insulation is provided for the heating mechanism.
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