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    FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇮 Finland

    DIARLEX ROTA-ADENO

    K Number: K942286 · Decision Dec 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    28
    Review Days
    236

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    Basic Information

    Device Name
    DIARLEX ROTA-ADENO
    K Number
    K942286
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Diagnostica, Inc.
    Date Received
    April 22, 1994
    Decision Date
    December 14, 1994
    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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