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

    PROPARAFLU+ ASSAY

    K Number: K132238 · Decision Aug 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    10
    Review Days
    39

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    Basic Information

    Device Name
    PROPARAFLU+ ASSAY
    K Number
    K132238
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gen-Probe Prodesse, Inc.
    Date Received
    July 18, 2013
    Decision Date
    August 26, 2013
    Product Code
    OOU
    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
    OOU Parainfluenza Multiplex Nucleic Acid Assay

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    Other Clearances by Gen-Probe Prodesse, Inc.

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    K132129 PRODESSE PROFLU+ ASSAY
    K123274 PROGASTRO SSCS ASSAY
    K123838 PRO HMPV+ ASSAY
    K110968 PROFLU+ ASSAY
    K102952 PRODESSE PROADENO
    K101855 PROFAST+ ASSAY