BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440

    K Number: K912666 · Decision Feb 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    54
    Review Days
    241

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    Basic Information

    Device Name
    DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
    K Number
    K912666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dako Corp.
    Date Received
    June 18, 1991
    Decision Date
    February 14, 1992
    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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    K991454 MOUSE IGG1 NEGATIVE CONTROLS
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    K971905 DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
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    K951965 DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
    Search all 54 clearances from Dako Corp. →