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

    ANTIGEN CONTROL CELLS

    K Number: K801507 · Decision Aug 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    24
    Review Days
    51

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    Basic Information

    Device Name
    ANTIGEN CONTROL CELLS
    K Number
    K801507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    June 30, 1980
    Decision Date
    August 20, 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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