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    K Number
    K993825
    Device Name
    PARA TECH PLUS RETICS
    Manufacturer
    STRECK LABORATORIES, INC.
    Date Cleared
    1999-11-30

    (18 days)

    Product Code
    JCN
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    JCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
    Device Description
    Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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