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

    IMMUNETICS C6 LYME ELISA KIT

    K Number: K003754 · Decision May 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    4
    Review Days
    156

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    Basic Information

    Device Name
    IMMUNETICS C6 LYME ELISA KIT
    K Number
    K003754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunetics, Inc.
    Date Received
    December 5, 2000
    Decision Date
    May 10, 2001
    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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    Other Clearances by Immunetics, Inc.

    K Number Device Name
    K040407 QUICKELISA ANTHRAX-PA KIT
    K991062 QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
    K991063 QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024