BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INFLAMMA DRY

    K Number: K132066 · Decision Nov 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    141

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    Basic Information

    Device Name
    INFLAMMA DRY
    K Number
    K132066
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1540
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Pathogen Screening, Inc.
    Date Received
    July 3, 2013
    Decision Date
    November 21, 2013
    Product Code
    PFQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PFQ Mmp-9 Test System

    Other Clearances by Rapid Pathogen Screening, Inc.

    K Number Device Name
    K110722 RPS ADENO DETECTOR PLUS