BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    ROTA-DAN RAPID ROTAVIRUS EIA KIT

    K Number: K951208 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    334

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    Basic Information

    Device Name
    ROTA-DAN RAPID ROTAVIRUS EIA KIT
    K Number
    K951208
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eldan Technologies, Ltd.
    Date Received
    March 17, 1995
    Decision Date
    February 14, 1996
    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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