LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K000410
    Device Name
    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2000-04-10

    (62 days)

    Product Code
    DMT
    Regulation Number
    862.3040
    Why did this record match?
    Product Code :

    DMT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K971506
    Device Name
    SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-06-03

    (39 days)

    Product Code
    DMT, DIC
    Regulation Number
    862.3040
    Why did this record match?
    Product Code :

    DMT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYNCHRON Systems Alcohol (ALC) Reagent, when used in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for the quantitative determination of alcohol in human serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
    Device Description
    The SYNCHRON Systems Alcohol (ALC) Reagent in conjunction with SYNCHRON Systems Alcohol Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
    Ask a Question

    Page 1 of 1