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

    BAYER LIGAND PLUS 1, 2, 3 CONTROLS

    K Number: K030452 · Decision Mar 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    32
    Review Days
    20

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    Basic Information

    Device Name
    BAYER LIGAND PLUS 1, 2, 3 CONTROLS
    K Number
    K030452
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Diagnostics Corp.
    Date Received
    February 11, 2003
    Decision Date
    March 3, 2003
    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 Bayer Diagnostics Corp.

    K Number Device Name
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    K031857 ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
    K022096 URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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    K023841 AMMONIA ASSAY FOR THE ADVIA 1650
    K022177 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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