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

    SYSCON CONTROL ASSAYED & UNASSAYED

    K Number: K954247 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    672
    Applicant Total
    19
    Review Days
    156

    Basic Information

    Device Name
    SYSCON CONTROL ASSAYED & UNASSAYED
    K Number
    K954247
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SCANTIBODIES LABORATORY, INC.
    Date Received
    September 11, 1995
    Decision Date
    February 14, 1996
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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