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

    ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU

    K Number: K790672 · Decision May 31, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    12
    Review Days
    55

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    Basic Information

    Device Name
    ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU
    K Number
    K790672
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3040
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostica, Inc.
    Date Received
    April 6, 1979
    Decision Date
    May 31, 1979
    Product Code
    JWT
    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
    JWT Antigen, Cf, Aspergillus Spp.

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