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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SENTINEL CERULOPLASMIN

    K Number: K051456 · Decision Oct 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    141

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    Basic Information

    Device Name
    SENTINEL CERULOPLASMIN
    K Number
    K051456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentinel Ch. Srl
    Date Received
    June 2, 2005
    Decision Date
    October 21, 2005
    Product Code
    JFR
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JFR Indirect Copper Assay, Ceruloplasmin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JFR), ordered by most recent decision date.

    CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM

    FDA 510(k)
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    Other Clearances by Sentinel Ch. Srl

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    K051111 SENTINEL UIBC LIQUID
    K051452 SENTINEL CLIN CHEM CAL
    K051115 SENTINEL IRON LIQUID
    K050836 CRP DIAGNOSTIC ASSAY
    K051457 SENTINEL PLASMAPROTEINS CAL 3X
    K051444 SENTINEL CHOLINESTERASE LIQUID