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

    GEMENI IGA ASSAY

    K Number: K800449 · Decision Mar 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    53
    Applicant Total
    41
    Review Days
    12

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    Basic Information

    Device Name
    GEMENI IGA ASSAY
    K Number
    K800449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    February 29, 1980
    Decision Date
    March 12, 1980
    Product Code
    CZP
    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
    CZP Iga, Antigen, Antiserum, Control

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    K871905 TOXOPLASMA GONDII IGG ELISA
    K870928 CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
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    K862640 AMYLASE LTS
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