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

    GAMMA COAT(125 I) RUBELLA ANTIBODY

    K Number: K801667 · Decision Oct 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    27
    Review Days
    94

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    Basic Information

    Device Name
    GAMMA COAT(125 I) RUBELLA ANTIBODY
    K Number
    K801667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Assays, Inc.
    Date Received
    July 21, 1980
    Decision Date
    October 23, 1980
    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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