BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

    K Number: K921421 · Decision Jul 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    27
    Review Days
    126

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    Basic Information

    Device Name
    LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
    K Number
    K921421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pro-Lab, Inc.
    Date Received
    March 24, 1992
    Decision Date
    July 28, 1992
    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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