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

    LEGIONELLA ELISA TEST SYSTEM

    K Number: K970149 · Decision Jun 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    135
    Review Days
    154

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    Basic Information

    Device Name
    LEGIONELLA ELISA TEST SYSTEM
    K Number
    K970149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zeus Scientific, Inc.
    Date Received
    January 15, 1997
    Decision Date
    June 18, 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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