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

    LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124

    K Number: K093815 · Decision Mar 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
    K Number
    K093815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Millipore Corporation
    Date Received
    December 14, 2009
    Decision Date
    March 12, 2010
    Product Code
    OMG
    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
    OMG Antisera, Fluorescent, Human Metapneumovirus

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    Other Clearances by Millipore Corporation

    K Number Device Name
    K081527 LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT