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

    VARELISA PR3-ANCA

    K Number: K953586 · Decision Jan 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    54
    Review Days
    178

    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
    VARELISA PR3-ANCA
    K Number
    K953586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    August 1, 1995
    Decision Date
    January 26, 1996
    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 Elias U.S.A., Inc.

    K Number Device Name
    K964385 ELIAS ANA-HEP-2
    K963291 VARELISA ANA (4) PROFILE
    K953873 VARELISA HELICOBACTER PYLORI ANTIBODIES
    K953587 VARELISA MPO-ANCA
    K951187 VARELISA CARDIOLIPIN ABS SCREEN
    K951205 VARELISA ANA PROFILE
    K951206 VARELISA PARIETAL CELL ANTIBODIES
    K951207 VARELISA HISTONE ANTIBODIES
    K944334 VARELISA COMBINED DNA ANTIBODIES EIA
    K951186 VARELISA ANA-4 SCREEN
    Search all 54 clearances from Elias U.S.A., Inc. →