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

    PREMIER COCCIDIOIDES

    K Number: K915493 · Decision Jul 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    92
    Review Days
    214

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    Basic Information

    Device Name
    PREMIER COCCIDIOIDES
    K Number
    K915493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3135
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Meridian Diagnostics, Inc.
    Date Received
    December 9, 1991
    Decision Date
    July 10, 1992
    Product Code
    MIY
    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
    MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

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