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

    PREMIER BLASTOMYCES

    K Number: K923859 · Decision Oct 5, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    92
    Review Days
    66

    Basic Information

    Device Name
    PREMIER BLASTOMYCES
    K Number
    K923859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3060
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MERIDIAN DIAGNOSTICS, INC.
    Date Received
    July 31, 1992
    Decision Date
    October 5, 1992
    Product Code
    MJL
    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
    MJL Eia, Blastomyces Dermatitidis

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