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

    EUROSPITAL EU-TTG IGA UMANA

    K Number: K010625 · Decision Apr 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    39
    Applicant Total
    14
    Review Days
    53

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    Basic Information

    Device Name
    EUROSPITAL EU-TTG IGA UMANA
    K Number
    K010625
    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
    March 2, 2001
    Decision Date
    April 24, 2001
    Product Code
    MVM
    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
    MVM Autoantibodies, Endomysial(Tissue Transglutaminase)

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    Other Clearances by Scimedx Corp.

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    K010289 SCIMEDX PHASE II MPO IGG ANTIBODY EIA
    K002189 GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
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    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
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