BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

    K Number: K983709 · Decision Oct 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    270
    Review Days
    7

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
    K Number
    K983709
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    October 21, 1998
    Decision Date
    October 28, 1998
    Product Code
    DIF
    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
    DIF Drug Mixture Control Materials

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