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

    ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

    K Number: K001127 · Decision Aug 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    115
    Review Days
    149

    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
    ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
    K Number
    K001127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    April 3, 2000
    Decision Date
    August 30, 2000
    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 The Binding Site, Ltd.

    K Number Device Name
    K231290 Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
    K090920 HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
    K083289 HUMAN BETA-2 MICROGLOBULIN KIT
    K082129 HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
    K081827 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
    K081674 BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
    K080384 HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
    K072889 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
    K070900 FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
    K062372 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
    Search all 115 clearances from The Binding Site, Ltd. →