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510(k) Data Aggregation

    K Number
    K965033
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-04-21

    (125 days)

    Product Code
    MGA
    Regulation Number
    866.5400
    Why did this record match?
    Product Code :

    MGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin in urine by rate nephelometry.
    Device Description
    The IMMAGE Immunochemistry System A1M Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of alpha-1-Other Fotom Calibration is interesmples on Beckman's IMMAGE™ Immunochemistry System.
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