BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

    K Number: K014173 · Decision Feb 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    28
    Applicant Total
    270
    Review Days
    57

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
    K Number
    K014173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3830
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    December 20, 2001
    Decision Date
    February 15, 2002
    Product Code
    DKJ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKJ Colorimetry, Salicylate

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