BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CCPOINT

    K Number: K093908 · Decision Dec 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    20
    Applicant Total
    6
    Review Days
    344

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    Basic Information

    Device Name
    CCPOINT
    K Number
    K093908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Euro-Diagnostica AB
    Date Received
    December 22, 2009
    Decision Date
    December 1, 2010
    Product Code
    NHX
    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
    NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

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    Other Clearances by Euro-Diagnostica AB

    K Number Device Name
    K091657 IMMUNOSCAN CCPLUS
    K062045 EDIA ANTI-CCP
    K971464 IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
    K971690 IMMUNOSCAN PR3-ANCA
    K971689 IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT