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

    EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

    K Number: K051489 · Decision Feb 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    6
    Review Days
    255

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
    K Number
    K051489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Euroimmun Us, LLC
    Date Received
    June 6, 2005
    Decision Date
    February 16, 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)

    Similar 510(k) Clearances

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

    Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)

    FDA 510(k)
    FDA Class 2 ·Immunology

    EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

    FDA 510(k)
    FDA Class 2 ·Immunology

    AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    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
    K060700 EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.