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

    APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

    K Number: K132251 · Decision Oct 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
    K Number
    K132251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic / Gen-Probe Incorporated
    Date Received
    July 19, 2013
    Decision Date
    October 17, 2013
    Product Code
    LSL
    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
    LSL Dna-Reagents, Neisseria

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