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

    PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

    K Number: K890768 · Decision Mar 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    12
    Review Days
    34

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    Basic Information

    Device Name
    PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
    K Number
    K890768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Genetic Systems Corp.
    Date Received
    February 15, 1989
    Decision Date
    March 21, 1989
    Product Code
    LYF
    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
    LYF Pneumocystis Carinii

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