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

    ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS

    K Number: K854129 · Decision Jan 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    28
    Review Days
    104

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    Basic Information

    Device Name
    ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
    K Number
    K854129
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Orion Diagnostica, Inc.
    Date Received
    October 9, 1985
    Decision Date
    January 21, 1986
    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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    Other Clearances by Orion Diagnostica, Inc.

    K Number Device Name
    K942286 DIARLEX ROTA-ADENO
    K914892 SALIVA-STIM
    K904655 PYLORISET
    K884074 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
    K884147 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
    K884075 IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
    K884040 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
    K864645 ADENOLEX (R) LATEX AGGLUTINATION TEST
    K871196 RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
    K862475 RESPIRASTICK ENZYME IMMUNOASSAY TEST
    Search all 28 clearances from Orion Diagnostica, Inc. →