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

    IMMUNO CONCEPTS ANCA TEST SYSTEM

    K Number: K974463 · Decision Feb 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    36
    Review Days
    75

    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
    IMMUNO CONCEPTS ANCA TEST SYSTEM
    K Number
    K974463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immuno Concepts, Inc.
    Date Received
    November 26, 1997
    Decision Date
    February 9, 1998
    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 Immuno Concepts, Inc.

    K Number Device Name
    K013432 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
    K013285 RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
    K013283 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
    K992041 RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
    K983924 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
    K972145 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
    K974478 IMMUNO CONCEPTS ANCA TEST SYSTEMS
    K963275 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
    K955605 RELISA JO-1 ANTIBODY TEST SYSTEM
    K955604 RELISA SM/RNP ANTIBODY TEST SYSTEM
    Search all 36 clearances from Immuno Concepts, Inc. →