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

    SYNCHRON CX3 DELTA

    K Number: K942676 · Decision Nov 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    56
    Applicant Total
    11
    Review Days
    149

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    Basic Information

    Device Name
    SYNCHRON CX3 DELTA
    K Number
    K942676
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman-Diagnostic Systems Group
    Date Received
    June 6, 1994
    Decision Date
    November 2, 1994
    Product Code
    JJF
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJF Analyzer, Chemistry, Micro, For Clinical Use

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