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

    ROTACUBE

    K Number: K884017 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    121
    Review Days
    124

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    Basic Information

    Device Name
    ROTACUBE
    K Number
    K884017
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Difco Laboratories, Inc.
    Date Received
    September 22, 1988
    Decision Date
    January 24, 1989
    Product Code
    LIQ
    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
    LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

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