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

    ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT

    K Number: K884026 · Decision Feb 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    93
    Review Days
    133

    Basic Information

    Device Name
    ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
    K Number
    K884026
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    OXOID U.S.A., INC.
    Date Received
    September 23, 1988
    Decision Date
    February 3, 1989
    Product Code
    GNA
    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
    GNA Antisera, All Types, Escherichia Coli

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