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

    LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT

    K Number: K081527 · Decision Apr 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    303

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    Basic Information

    Device Name
    LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
    K Number
    K081527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Millipore Corporation
    Date Received
    June 2, 2008
    Decision Date
    April 1, 2009
    Product Code
    GQL
    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
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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    Other Clearances by Millipore Corporation

    K Number Device Name
    K093815 LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124