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

    LIGAND PLUS CONTROL LEVEL 1-3

    K Number: K033344 · Decision Jan 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    LIGAND PLUS CONTROL LEVEL 1-3
    K Number
    K033344
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Technology
    Date Received
    October 20, 2003
    Decision Date
    January 16, 2004
    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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    Other Clearances by Consolidated Technology

    K Number Device Name
    K023731 QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
    K020237 IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
    K003716 CONFORMANCE CHEMISTRY CONTROL C3