BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES

    K Number: K890281 · Decision Mar 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    109
    Applicant Total
    5
    Review Days
    57

    Basic Information

    Device Name
    HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
    K Number
    K890281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    CAMBRIDGE BIOSCIENCE CORP.
    Date Received
    January 17, 1989
    Decision Date
    March 15, 1989
    Product Code
    LSR
    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
    LSR Reagent, Borrelia Serological Reagent

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