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510(k) Data Aggregation

    K Number
    K993441
    Device Name
    K-ASSAY ALPHA-1 AG
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-24

    (43 days)

    Product Code
    LKL
    Regulation Number
    866.5420
    Why did this record match?
    Product Code :

    LKL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K964299
    Device Name
    N-ASSAY TIA MULTI V-NL
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (258 days)

    Product Code
    LKL
    Regulation Number
    866.5420
    Why did this record match?
    Product Code :

    LKL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Alpha-l-Acid Glycoprotein Test Kit is intended for the quantification of human alpha-l-acid glycoprotein in human serum by immunoturbidimetric assay. Measurement of alpha 1acid glycoprotein may aid in the diagnosis of collagen ( connective tissue ) disorders, tuberculosis, infections, extensive malignancy and diabetes.
    Device Description
    Not Found
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    K Number
    K964257
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-03-24

    (150 days)

    Product Code
    LKL
    Regulation Number
    866.5420
    Why did this record match?
    Product Code :

    LKL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.
    Device Description
    The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.
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