BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MYCOPLASMA PNEUMONIAE CF ANTIGEN

    K Number: K834338 · Decision Feb 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    33
    Review Days
    77

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    Basic Information

    Device Name
    MYCOPLASMA PNEUMONIAE CF ANTIGEN
    K Number
    K834338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3375
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hillcrest Biologicals
    Date Received
    December 12, 1983
    Decision Date
    February 27, 1984
    Product Code
    GSB
    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
    GSB Antigens, Cf, All, Mycoplasma Spp.

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