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

    EIA KIT FOR THE DETECTION OF GBM ANTIBODIES

    K Number: K953495 · Decision Apr 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    14
    Review Days
    259

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    Basic Information

    Device Name
    EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
    K Number
    K953495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scimedx Corp.
    Date Received
    July 26, 1995
    Decision Date
    April 10, 1996
    Product Code
    DBL
    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
    DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

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    Other Clearances by Scimedx Corp.

    K Number Device Name
    K011348 PHASE II GBM IGG ANTIBODY EIA TEST
    K011082 TPO IGG ANTIBODY EIA TEST
    K010625 EUROSPITAL EU-TTG IGA UMANA
    K010287 SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
    K010289 SCIMEDX PHASE II MPO IGG ANTIBODY EIA
    K002189 GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
    K002169 GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
    K002107 IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
    K994379 EU-TTG IGA ELISA
    K970198 IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
    Search all 14 clearances from Scimedx Corp. →