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

    IMMULITE 2000 ANTI-CCP IGG ASSAY

    K Number: K121576 · Decision Apr 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    20
    Applicant Total
    152
    Review Days
    309

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    Basic Information

    Device Name
    IMMULITE 2000 ANTI-CCP IGG ASSAY
    K Number
    K121576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    May 30, 2012
    Decision Date
    April 4, 2013
    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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