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510(k) Data Aggregation

    K Number
    K971287
    Device Name
    SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-05-08

    (31 days)

    Product Code
    DKB
    Regulation Number
    862.3200
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K955644
    Why did this record match?
    Device Name :

    SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS, when used in conjunction with SYNCHRON Gentamicin Reagent and Tobramycin Reagent, is intended for use on the SYNCHRON Systems and for the calibration of gentamicin and tobramycin.

    Device Description

    The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is for use in the calibration of SYNCHRON Systems Gentamicin and Tobramycin chemistries. The SYNCHRON Systems DRUG CALIBRATOR 3 PLUS is a liquid human serum matrix to which gentamicin and tobramycin are added.

    AI/ML Overview

    This is a calibrator for a drug test, not an AI device. The requested information does not apply in this context.

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