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

    RUBELLA ANTIBODY FLUOROIMMUNOASSAY

    K Number: K841174 · Decision Jun 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    29
    Review Days
    80

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    Basic Information

    Device Name
    RUBELLA ANTIBODY FLUOROIMMUNOASSAY
    K Number
    K841174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    March 19, 1984
    Decision Date
    June 7, 1984
    Product Code
    GOL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GOL Antigen, Ha (Including Ha Control), Rubella

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    K840867 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
    K834140 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
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