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510(k) Data Aggregation

    K Number
    K950148
    Device Name
    CHEMMATE(TM) CD43
    Date Cleared
    1996-07-02

    (532 days)

    Product Code
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEK SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The BioTek Solutions ChemMate™ CD43 is used in combination with the automated TechMate™ staining instrument. The instrumentation and methods employ the capillary action principle, covered by U.S. patent 4,731,335 (and others) and are held by BioTek Solutions, Inc. The instrumentation consists of two parts; the instrument's mechanical arm with its associated work station and the PC-style computer with mouse and color monitor. The mechanical arm picks up and places the slide holder containing test slides on the appropriate "tile" or platform. Solutions and pads are mounted on the tiles in a pattern described by the protocol. The instrument performs the following functions: - Moves the slide holder(s) from one tile position (containing chemistry or pad) to another. - By capillary action adds immunological or chemical reagents in proper sequence as dictated by the protocol instructions. - Employs uniform washing procedures between reagent steps, as per the loaded protocol. - Keeps immunologic reaction conditions uniform by controlling time of incubation and volume of reagent used. - Records real time for incubation steps with the reagent used for the specific step. - Standardizes the immunohistochemistry procedure. There are two reagent sets in addition to the CD43 (primary antibody) and the Negative Control Reagent. These are the Secondary Detection Kit -Peroxidase/DAB (SDK605) and the Standard Secondary Buffer Kit (SDK601A). All of the ChemMate™ reagents are designed for use with the TechMate™ instrument.
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    K Number
    K936111
    Device Name
    CHEMMATE SPECIAL STAIN LCA-CD45
    Date Cleared
    1996-02-27

    (796 days)

    Product Code
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTEK SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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