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510(k) Data Aggregation

    K Number
    K973055
    Device Name
    WAKO CH50 LINEARITY SET
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    1997-09-25

    (41 days)

    Product Code
    JIW
    Regulation Number
    862.1150
    Why did this record match?
    Product Code :

    JIW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CH50 Linearity Set is to be used with WAKO Autokit CH50 test for the estimation of the linearity limits of the reagent/instrument system for the CH50 analyte.
    Device Description
    Not Found
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    K Number
    K970396
    Device Name
    HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
    Manufacturer
    DADE CHEMISTRY SYSTEMS, INC.
    Date Cleared
    1997-02-20

    (17 days)

    Product Code
    JIW
    Regulation Number
    862.1150
    Why did this record match?
    Product Code :

    JIW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
    Device Description
    The Human Chorionic Gonadotropin (HCG) Calibrator for the Dimension® RxL system is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable hCG. Levels 2 through 5 contain human unne chorionic gonadotropin. The kit consists of ten vials; two at each of five levels.
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