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

    ROTACLONE ROTAVIRUS DIAGNOSTIC KIT

    K Number: K852969 · Decision Nov 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    32
    Applicant Total
    5
    Review Days
    113

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    Basic Information

    Device Name
    ROTACLONE ROTAVIRUS DIAGNOSTIC KIT
    K Number
    K852969
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3405
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Cambridge Bioscience Corp.
    Date Received
    July 15, 1985
    Decision Date
    November 5, 1985
    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 Cambridge Bioscience Corp.

    K Number Device Name
    K890281 HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
    K881894 ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
    K873082 ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST
    K873312 ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST