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

    ENZYGNOST ROTAVIRUS AG

    K Number: K841243 · Decision Oct 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    145
    Review Days
    208

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    Basic Information

    Device Name
    ENZYGNOST ROTAVIRUS AG
    K Number
    K841243
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    March 23, 1984
    Decision Date
    October 17, 1984
    Product Code
    LIQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    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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