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

    PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

    K Number: K981913 · Decision Feb 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    6
    Review Days
    256

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    Basic Information

    Device Name
    PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
    K Number
    K981913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chembio Diagnostic Systems, Inc.
    Date Received
    June 1, 1998
    Decision Date
    February 12, 1999
    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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