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

    EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

    K Number: K060700 · Decision Sep 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    6
    Review Days
    177

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    Basic Information

    Device Name
    EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
    K Number
    K060700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Euroimmun Us, LLC
    Date Received
    March 15, 2006
    Decision Date
    September 8, 2006
    Product Code
    MOB
    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
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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    Other Clearances by Euroimmun Us, LLC

    K Number Device Name
    K070789 EUROIMMUN ANTI-CCP ELISA
    K061239 EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
    K070763 EUROIMMUN ANA IFA: HEP-20-10
    K061408 EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
    K051489 EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM