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

    LEGIONELLA IGG/IGM ELISA TEST SYSTEM

    K Number: K963318 · Decision Mar 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    68
    Review Days
    192

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    Basic Information

    Device Name
    LEGIONELLA IGG/IGM ELISA TEST SYSTEM
    K Number
    K963318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Armkel, LLC
    Date Received
    August 23, 1996
    Decision Date
    March 3, 1997
    Product Code
    LHL
    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
    LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

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