BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

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

    K Number: K140225 · Decision Oct 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    22
    Review Days
    271

    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
    ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
    K Number
    K140225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    January 29, 2014
    Decision Date
    October 27, 2014
    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

    QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

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

    Other Clearances by Phadia US, Inc.

    K Number Device Name
    K141375 ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
    K132631 EIA SMDP IMMUNOASSAY
    K131821 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
    K122197 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
    K113841 IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
    K112414 ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
    DEN120001 IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
    K111919 IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
    K102673 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
    K093459 ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
    Search all 22 clearances from Phadia US, Inc. →