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

    QUICKELISA ANTHRAX-PA KIT

    K Number: K040407 · Decision Jun 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    107

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    Basic Information

    Device Name
    QUICKELISA ANTHRAX-PA KIT
    K Number
    K040407
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3045
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunetics, Inc.
    Date Received
    February 17, 2004
    Decision Date
    June 3, 2004
    Product Code
    NRL
    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
    NRL Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

    Other Clearances by Immunetics, Inc.

    K Number Device Name
    K003754 IMMUNETICS C6 LYME ELISA 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