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

    REAGENTS FOR SERODIAGNOSIS OF ASPERGILL

    K Number: K812740 · Decision Oct 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    21

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    Basic Information

    Device Name
    REAGENTS FOR SERODIAGNOSIS OF ASPERGILL
    K Number
    K812740
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3040
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Nolan Biological Laboratories, Inc.
    Date Received
    September 29, 1981
    Decision Date
    October 20, 1981
    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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    ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU

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    Other Clearances by Nolan Biological Laboratories, Inc.

    K Number Device Name
    K812741 REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
    K802129 IMMUNODIFFUSION REAGENTS/SEROLOGICAL
    K802130 IMMUNO. IDENTIFICATION OF H. CAPSULATUM
    K802128 IMMUNODIFFUSSION REAGENTS/SEROLOGICAL