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

    THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY

    K Number: K936010 · Decision Jul 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    10
    Review Days
    214

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    Basic Information

    Device Name
    THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
    K Number
    K936010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomerica, Inc.
    Date Received
    December 16, 1993
    Decision Date
    July 18, 1994
    Product Code
    DDC
    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
    DDC Thyroglobulin, Antigen, Antiserum, Control

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