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

    BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

    K Number: K042579 · Decision Jul 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    309

    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
    BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
    K Number
    K042579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5785
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Binding Site
    Date Received
    September 22, 2004
    Decision Date
    July 28, 2005
    Product Code
    NBT
    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
    NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

    Similar 510(k) Clearances

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

    ASCA-CHEK

    FDA 510(k)
    FDA Class 2 ·Immunology

    TECHLAB ASCA-CHEK

    FDA 510(k)
    FDA Class 2 ·Immunology

    AESKULISA ASCA A

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

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

    Other Clearances by The Binding Site

    K Number Device Name
    K140105 HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
    K132555 HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
    K103824 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
    K100455 SPAPLUS ANALYZER
    K092450 HUMAN IGD KIT FOR USE ON SPAPLUS
    K072166 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
    K042152 BINDING SITE IGG SUBLCASS OLYMPUS KITS
    K041891 MININEPH HUMAN RHEUMATOID FACTOR KIT
    K040466 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS