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

    EUROIMMUN ANTI-CCP ELISA

    K Number: K070789 · Decision Dec 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    20
    Applicant Total
    6
    Review Days
    284

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    Basic Information

    Device Name
    EUROIMMUN ANTI-CCP ELISA
    K Number
    K070789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Euroimmun Us, LLC
    Date Received
    March 22, 2007
    Decision Date
    December 31, 2007
    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 Euroimmun Us, LLC

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    K061408 EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
    K060700 EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
    K051489 EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM