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

    ORTHO* ROTAVIRUS ANTIGEN ELISA TEST

    K Number: K883935 · Decision Jan 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    126
    Review Days
    107

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    Basic Information

    Device Name
    ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
    K Number
    K883935
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    September 19, 1988
    Decision Date
    January 4, 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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